MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-19 for INFLOW INTRAURETHRAL VALVE-PUMP 203511-35 manufactured by Vesiflo, Inc., Redmond, Wa.
[136604873]
Event investigation: vesiflo reviewed all available records pertaining to this patient: batch records for lots 5024a and 5036 were reviewed. Subject devices met all requirements. Vesiflo shipping records show that a device was sent to the patient on (b)(6) 2016 and medical records show this initial device was inserted by her physician. Medical records show that a device migration occurred in (b)(6) 2016, the second month of the patient's device use, that this device was uneventfully removed via cystoscopy and that the patient requested to return to device use. Vesiflo shipping records show that a total of 10 devices were sent to the patient's home between may 2016 and jan 2017 and that two devices were sent in (b)(6) 2017. In addition, quarterly shipments were made to the patient's physician in (b)(6) of 2017; however, in (b)(6) 2018 the physician's office returned all nine of these devices, because the patient had not come to the office for device replacements. Accordingly, vesiflo considered this patient to have been terminated from device use as of (b)(6) 2017, the last documented device replacement. If all devices had been used for one month each as required in the inflow's instructions for use, it is not clear how the patient could have possessed a device in (b)(6) 2018, the date she claims to have self-inserted the device involved in this incident. Conclusion: the patient's physician reports that: the patient is non-compliant. The patient is a poor historian. He wonders if the device had been in much longer than the patient reports based on the difference in the physical condition of the device involved in this incident as compared to the first migrated device removed from this patient. Vesiflo's review of all available records indicates that the device involved in this incident may have been in the patient's bladder for as long as 16 months before she sought medical help. Therefore, vesiflo concludes that this incident was the result of patient non-compliance with the device instructions for use and the physician's plan of care. The relationship, if any, of the device to the reported incident or adverse event: based on its examination of the medical records, vesiflo concludes that the device was not at fault in this event. If the patient had followed the device instructions for use (ifu), which are to replace the device monthly and if it migrates to the bladder to seek immediate medical attention, then no surgery would have been necessary and no reportable event would have occurred. The patient reported that she was in possession of a device that she inserted herself, that this device migrated into her bladder and that she requested removal about six weeks after insertion. Her physician has stated that this patient is non-compliant and a poor historian. Prior experience with device migration and extensive biocompatibility testing also contradict the likelihood of her account: device migration had occurred previously with this patient and the migrated device was promptly and uneventfully removed via cystoscopy, as it has in all other cases of device migration. Of note, the device that was previously removed was completely intact and in good physical condition, again as has been reported in all prior cases of device migration. It is likely that in this instance the removed device was fragmented by unsuccessful attempts to remove it cystoscopically. As device migration is known to occur with device use, it is listed as a possible complication in the inflow's ifu. Device migration is a relatively rare event; however, and is usually the result of sexual intercourse in a non-recommended position. Only one instance was reported in 2928 weeks of device use in the inflow's pivotal trial. Vesiflo has also recently become aware of two instances of device migration in u. S. Clinical use that do not involve this patient, both of which were uneventfully resolved. These instances were not reported to the company, but were identified via a post-market survey. It seems likely that the device involved in this incident was in the patient's bladder longer than she reports, possibly as for long as 16 months: per her medical records, the patient's most recent device insertion occurred in (b)(6) 2017, which is 16 months prior to her (b)(6) 2018 physician visit. As noted earlier in this document, vesiflo's records show that if the patient was following inflow ifu and physician instructions, i. E. Replacing devices every 29 days, she should not have been in possession of a device to insert in (b)(6) 2018. There was a very high level of encrustation on the removed device, whereas no encrustation was observed on the previously removed device. Cystoscopic examination of the patient's urethra prior to device removal revealed no signs of encrustation, indicating that it occurred in the bladder. The inflow device has been in clinical use for over 20 years and nothing like the level of encrustation that occurred with this patient has ever been reported. No instances of device encrustation occurred at all in 2928 weeks of device use in the inflow's pivotal trial. Also, a laboratory test by stickler et al showed that inflow is highly resistant to encrustation under conditions of normal use. Therefore, vesiflo concludes that: this event was the result of the patient's non-compliance with both the device instructions for use and her physician's plan of care and her non-compliance was likely extreme, leaving a migrated device in her bladder for as long as 16 months before seeking medical help.
Patient Sequence No: 1, Text Type: N, H10
[136604874]
The following is a summary of the patient's history as reported by the physician: the female patient, age (b)(6) has spina bifida and as a result she does not have the ability to empty her bladder without a bladder drainage device. She began using the inflow device in (b)(6) 2016 as her bladder drainage method. In (b)(6) 2016, the second month of device use, the patient pushed the inflow device into her urethra, which then migrated into her bladder. It was retrieved shortly thereafter by cystoscope. The physician reported that the device was intact and appeared normal. The patient stated that she wanted to go back on device on (b)(6) 2016 and did so with physician approval. On (b)(6) 2018 patient visited her physician's office and reports that: she inserted inflow device into her urethra about a month ago, she pushed it further into her urethra and believes it migrated into her bladder about 2 weeks after she inserted it, and the device has been in bladder at least 3 weeks (est. ). She reports no pain but thinks she might have uti. Nurse places a catheter to enable her to drain her bladder and notes malodorous, cloudy urine draining from bladder. Inflow device was palpated in the bladder. Physician notes no tenderness, no mass, no scarring to urethra. On (b)(6) 2018 patient returns to physician's office and reports that she thinks the catheter placed on (b)(6) in is no longer in the right place since she is leaking. Physician reports it is in place and that blood tinged urine is draining. She is on bactrim and does not have fever, chills or flank pain. Urine culture results per (b)(6) 2018 final report show no growth. On (b)(6) 2018 patient returns to office for cystoscopy to remove inflow device in bladder. Physician looked for device in bladder with urethroscope and upon locating the device in the bladder determined the device could not be removed by cystoscopy through the urethra because of the "massive calcified device," i. E. Encrustation. Dr. Reported that on x-ray he could see a "large stone" on device. Physician communicated that a suprapubic vesicostomy would be required to remove device. Patient elected to wait for removal until (b)(6) because of personal plans in late (b)(6). Surgery was performed (b)(6) 2018 to remove device. Patient was given iv antibiotics and general anesthesia. First, cystoscopy was performed and located "a large foreign body and stone at the base. " when physician made incision to open bladder to remove device, he reports the device was fragmented and a large calcification was observed. All foreign elements were reported to be removed. Patient was closed up and moved to recovery in stable condition with a foley catheter for bladder drainage. She was sent home with oral antibiotics and narcotics for pain control. On (b)(6) 2018 patient returns to physician's office for post-op visit and reports that she has not had post-operative fever, nausea or vomiting and she does have good appetite and bowels moving normally. She reports she does have incisional drainage, but no pain or swelling or redness or erythema around incision. She says the wound has opened up and that she thinks there has been bleeding. She is taking bactrim and lamictal and at visit keflex is added. Aerobic and anaerobic culture sent to lab. On (b)(6) 2018 patient returns for repeat wound check. Nurse notes that patient is still taking keflex and thinks she senses an odor from incision. Patient reports improvement and is packing w-d bid. Physician noted wound healing well, some drainage, and repacked. Patient is taking keflex and lamictal. On (b)(6) 2018 urinalysis report shows abnormal anaerobic growth and no aerobic culture growth. Patient returned to office on (b)(6) 2018 for post-op visit and catheter check and reports improvement in abdominal wound, that she is performing dressing changes, does not have fever or chills and denies any urinary complaints at this time. She says she is having problem with her indwelling catheter and thinks it is out of place because she is leaking urine into diaper. Her bag stopped draining 2 days ago. Physician reminds her that she needs to see infectious disease regarding uti. Urine culture was sent to lab. Notes mention foley catheter present but no drainage. On (b)(6) 2018 physician sent email to (b)(6) of vesiflo reporting event and that patient had infection and was being treated with antibiotics. On (b)(6) 2018 vesiflo telephoned the physician to discuss the incident. On (b)(6) 2018 vesiflo spoke with physician's office to request any additional visit records since (b)(6) 2018. Vesiflo was told the surgical wound is healing well, but patient returned to physician's office (b)(6) 2018 because she is pulling out the indwelling catheter the physician placed to enable her bladder to drain. They have not noted any further complications of the surgery to remove the device from her bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011421900-2019-00001 |
| MDR Report Key | 8350483 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-09-07 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN CONNOLLY |
| Manufacturer Street | 8531 154TH AVENUE NE SUITE 150 |
| Manufacturer City | REDMOND, |
| Manufacturer G1 | PRIMO MEDICAL GROUP, INC. |
| Manufacturer Street | 75 MILL STREET |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLOW INTRAURETHRAL VALVE-PUMP |
| Generic Name | URETHRAL INSERT WITH PUMP FOR BLADDER DRAINAGE |
| Product Code | PIH |
| Date Received | 2019-02-19 |
| Model Number | 203511-35 |
| Catalog Number | 203511-35 |
| Lot Number | POSSIBLY LOT # 5036 |
| Device Expiration Date | 2019-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VESIFLO, INC., REDMOND, WA |
| Manufacturer Address | 8531 154TH AVENUE NE SUITE 150 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-19 |