MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-12-21 for STONEBREAKER PNEUMATIC LITHOTRIPTER SBL-KIT1 manufactured by Cook Inc.
[95585799]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[95585800]
The foreign reporter stated that the patient was brought to the urology department of the hospital to have a 3 cm kidney stone removed on (b)(6) 2016. During the percutaneous nephrolithotomy procedure to remove the 3 cm kidney stone from the right kidney, the stonebreaker pneumatic lithotripter co2 cartridge gas "ran out? At 11:15 am. No further details regarding the co2 cartridge or the event were provided. They stopped the surgery but they kept some form of the anesthesia going. The sales representative was called and asked to bring additional co2 cartridges. The sales representative informed them that it would take more than 1-1. 5 hours to deliver the additional cartridges. The sales representative provided the nursing staff sterile, non-expired co2 cartridges 1. 5 hours after the phone call. It was reported that the procedure was completed between 18:00 and 19:00. After the surgery, the patient had several lifesaving interventions, then he was taken to the emergency unit and it was reported the patient expired 19 days later on (b)(6) 2016. It was reported the patient's son stated he was receiving contradictory information about his father's condition. The son believes the "death of the patient is related to the treatment and the after-treatment". No information was provided as to what caused the patient death. On 22nov2017 additional information was received from the sales representative who stated the facility is not willing to give up the stonebreaker as they state the device currently works properly and is needed for upcoming procedures. On 19dec2017 it was reported that the sales representative understands from discussions with a local authority that they are investigating the sterilization procedure used by the hospital for the stonebreaker device and possible reuse by the hospital of a co2 cartridge. The instructions for use (ifu) gives cleaning and sterilizing instructions. The co2 gas cartridge is not supposed to be reused and the instructions are to let the excess gas out and remove the cartridge after the procedure is completed.
Patient Sequence No: 1, Text Type: D, B5
[106279873]
Additional information as provided by the clinic director. The following report has been provide by the clinic director. The report includes a summary of the sequence of events leading to the patient's death as well as the doctors medical opinion as to the cause of death. The patient was admitted to our department on (b)(6) 2016 because of bilateral kidney stones, and for the percutaneous surgery of the stones, which were filling the entire right-side renal pelvis. The percutaneous nephrolithotomy (pcnl) surgery was performed on (b)(6) 2016 after standard preparations. Despite the patient having a personal attachment to me, the operation (in accordance with the practice at our clinic) was passed on to the leader of the upper urinary tract endoscopic working group, with the consent of the patient (the name of the person performing the surgery was incorrect in the documentation. ) during the surgery, the lithotripsy was initiated using pressurised carbon-dioxide cartridges as the energy source, but the two available cartridges (roughly 80 shocks/cartridge) ran out much more quickly than expected (20-25 shocks/cartridge), so we switched to laser lithotripsy. However, the stone was too hard for this type of energy, and it resisted even after almost one and a half hours of lithotripsy. Meanwhile, we learned that carbon-dioxide cartridges would be available within an hour, so with the anaesthetic keeping the patient? S condition stable, the surgery was suspended, and we decided to wait for the new cartridges and continue the procedure with them. The surgery continued after the cartridges arrived. The majority of the stone was removed, but as time had progressed, it was decided to stop the surgery, leaving a stone fragment in the body. At the end of the operation, the standard nephrostomy tube was left in the patient, and for safety? S sake a dj catheter as well, because a little contrast medium discharge was noticed from the pelvic cavity. No other complications or significant bleeding were observed during the surgery. Bleeding was noticed during postoperative observation in the intensive care unit. Consequently, the specialist on duty , who also assisted in the surgery, recommended plugging the standard nephrostomy tube and performing checks. During the evening, following a telephone call from relatives, i went into the intensive care unit, where the ultrasound follow-up examination was being performed, to check on the patient. Based on this and on the severe postoperative bleeding diagnosed by then with physical signs, i decided to operate immediately. The urgent blood preparation ordered one and a half hours previously had not yet arrived by then. In the operating theatre, while exploring the retroperitoneum and the abdominal cavity, a significant amount of blood and blood mixed with rinsing fluid was removed; squirting blood was visible from the site where the nephrostomy tube has been removed from the kidney, so we performed an immediate nephrectomy. During the urgent nephrectomy, the double j catheter, in an appropriate position, was clearly visible in the just-opened renal pelvis. After this, the care of the patient continued at the intensive care unit. The attending physicians can provide accurate information about these details. What is certain is that our patient was constantly in a severe, critical condition after this; he required mechanical ventilation, circulatory support and continuous dialysis. The second surgery was performed because of significant, sudden bleeding of the abdominal cavity noticed at the icu. The entire abdominal cavity was explored during the surgery, for which dr (b)(6), surgeon, who was in the clinic at the time, was also called in. He could not find any specific source of bleeding in the abdominal cavity for treatment. However, the patient was bleeding diffusely from almost all his retroperitoneal tissue; the haemorrhage also affected the contralateral, intact retroperitoneum. The diffuse bleeding, indicating dic, was partially treated, but as it could not be treated completely, the retroperitoneum was tamponaded with large abdominal wipes that were left in the body, and the surgical wound was closed like this. In the postoperative period spent at the icu, the patient was still in a critical condition and through the 2 (retroperitoneal and intraabdominal) drains left in the body, no further significant bleeding was observed. After 48 hours, in light of his critical condition, the abdominal wipes were removed at the icu with a mini lumbotomy. In the following postoperative period, the patient? S condition did not improve, and no significant bleeding nor other discharge was observed through the drains, so they were removed after a few days. During the daily follow-up examinations of the patient in a critical condition, necrosis of the scrotal skin and inguinal skin region were observed as the first sign of severe peripheral circulatory failure, but because of his critical condition in general, no surgical intervention was considered then. One or two days after this, faecal discharge was observed at the site of the abdominal drain. During the urgent reoperation, the specialist surgeon asked to perform the surgery observed more segmental necrotic areas along a 70 cm long section of the small intestine and at the area of the sigmoid colon. He also saw three orifices on the small intestine corresponding to the necrotic areas. A resection of the small intestine and a colectomy were performed. The patient? S condition did not improve after the surgery, and, despite the intensive care, he died. To sum up, it is my opinion the patient died because of the following tragic series of events: as a complication of the percutaneous surgery, severe arterial bleeding occurred from the injection site, resulting in significant blood loss; the patient had haemorrhagic shock because of this, which was exacerbated by the late arrival of the blood supply. The patient? S blood-loss condition was worsened further by the delay in surgery caused by technical reasons, the stone proving much more difficult to break than expected, and the more significant water load stemming from the rinsing fluid over this time (tur syndrome); dic developed as a result of the extreme blood loss and the tur syndrome, owing to the critical condition continuing for weeks, the dialysis treatment, the multiple reoperations and for the reasons outlined above, a severe microcirculatory disturbance developed at the splanchnic areas and on the periphery, which led to necrosis, bowel necrosis, perforation and, finally, to the death of the patient. Details were also provided regarding the procedure. It was reported that anesthesia started at 11:15 am. During the procedure lithotripsy was performed until about 2:00 pm when the second co2 cartridge emptied. Laser lithotripsy was switched to for about a half of an hour. At that time the cook representative was called. The surgery was initiated again not long before 4:00 pm with the newly arrived cartridges. The surgery was ended before 5:00 pm.
Patient Sequence No: 1, Text Type: N, H10
[106909107]
Investigation? Evaluation the stonebreaker pneumatic lithotripter device was not returned for an analysis and no photos were provided. Without the complaint device, a physical investigation was not able to be completed. A document based investigation has been performed which includes a review of manufacturing records, service records, the instructions for use, manufacturing instructions, quality control data, and specifications. A review of the manufacturing records shows this device was manufactured to specifications prior to release and shipped to the customer? S site in (b)(6) 2012. There have been no other complaint reports received on this device. The stonebreaker nor the cartridges have been returned for analysis or service. This reusable device was well beyond the 12-month warranty period. Even though the device issue was observed, the device continued to be used for the procedure and was never returned to the manufacturer. The site declined to return as they are still actively using the device. The stonebreaker pneumatic lithotripter device is a portable, non-electrical, compact intracorporeal lithotripter, intended to fragment stones in the urinary tract. Cook has requested the device from the user facility, however, information was received that indicates the site was declining to return the device as they are still actively using the device. The co2 cartridge of the device is received into a cavity located in the anodized aluminum body. It engages a punch and o-ring which punctures the cartridge and creates a seal as the cartridge holder is tightened to engage the cartridge in the device. The instructions for use (ifu) that accompanies this device provides the following related information: a stonebreaker carbon dioxide (co2) gas cartridge typically provides the necessary energy for one surgical procedure. Once the cartridge is perforated by the built-in screw system, the compressed gas passes through a pre-adjusted pressure regulator in the device and a mechanical shockwave required for fragmentation of urinary stone is generated when the trigger is depressed. One full stonebreaker carbon dioxide gas cartridge should allow delivery of at least 80 shocks. The cartridge must be removed from the device after the completion of the surgical operation to allow complete release of gas from the cartridge. Precautions the stonebreaker must be used only by a specialist trained in endourology and should be used for the purposes intended. In case of malfunction or failure of the device, it is recommended that the surgeon have another unit (or other intracorporeal lithotripsy device) on standby in order to complete the treatment scheduled at the time. It is recommended that extra probes be available in case of malfunction. Pre-use preparation 7. Insert a new stonebreaker carbon dioxide gas cartridge into the cartridge older and tighten to hold the cartridge in place but without perforating it. Caution: do not perforate the cartridge until immediately before advancing the probe through the endoscope to treat the stone. Leaving a perforated carbon dioxide gas cartridge in the device for too long may adversely affect the performance of the device. Intracorporeal lithotripsy procedure note: one new full stonebreaker carbon dioxide cartridge should allow delivery of at least 80 shocks. 5. Once the procedure is complete, remove the carbon dioxide cartridge from the cartridge holder by loosening the lever slowly. This will allow any remaining gas in the cartridge to escape, thereby emptying the cartridge. Caution: do not sterilize the spent cartridge with the device. The troubleshooting section of the ifu indicates more than one solution to address instances of a gas leak such as tightening the cartridge holder fully, returning the device to the manufacturer for servicing, and using an alternate device. Based on the complaint report, the device does not appear to be providing the indicated number of shocks. The ifu indicates to return the device for maintenance when this is observed at which time a service technician would replace the o-rings. The stonebreaker reusable device was well beyond the 12-month warranty period at the time of the reported event. Even though the device issue was observed, use of the device continued for the procedure. This device has been in use for approximately 6 years. There is no indication that a design or process related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. Per the physician, the patient? S death was a result of a complication of the percutaneous surgery leading to severe arterial bleeding occurring from the injection site. This resulted in significant blood loss which in combination with a delay in a blood transfusion led to hemorrhagic shock and subsequent complications. The device not providing the indicated greater than 80 shocks and the stone being more difficult to break than expected resulted in a delay in the lithotripsy procedure. The patient having a more significant water load was believed to have contributed to the patient? S blood loss condition. However, the physician also noted that patient was in a stable condition following the lithotripsy. The patient developed dic as a result of the blood loss and tur syndrome. The patient was in critical condition for weeks with multiple interventions performed. In the end, the patient began experiencing a severe microcirculatory disturbance at the splanchnic area which led to bowel necrosis and perforation until the patient eventually expired. Neither the stonebreaker nor cartridges were returned for analysis therefore no conclusions can be drawn based on the current condition of the device beyond the initial report and information from the physician. Based on the information available, the patient? S death is reportedly due to blood loss leading to a microcirculatory disturbance, bowel necrosis, and bowel perforation. The device is not directly related to the patient? S death per the physician? S statement. Measures have been initiated to address the reported failure mode. The appropriate cook personnel have been notified of this event. Per the quality engineering risk assessment, no further action is warranted. Monitoring will continue to be performed for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-04602 |
| MDR Report Key | 7141409 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-12-21 |
| Date of Report | 2018-02-07 |
| Date of Event | 2016-11-15 |
| Date Mfgr Received | 2018-04-10 |
| Date Added to Maude | 2017-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONEBREAKER PNEUMATIC LITHOTRIPTER |
| Product Code | FFK |
| Date Received | 2017-12-21 |
| Catalog Number | SBL-KIT1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-12-21 |