MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-07-13 for 7.5CM ANTERIOR/POSTERIOR RR 750 manufactured by Arthrocare Corp..
[49490559]
Patient Sequence No: 1, Text Type: N, H10
[49490560]
It was reported that a hospitalized cardiac patient was treated for a nosebleed using a rr900. The patient subsequently experienced delirium (or acute confused state). During that state, he allegedly pushed the rr900 through his nose into the larynx and died due to suffocation. The emergency room team was unable to resuscitate the patient.
Patient Sequence No: 1, Text Type: D, B5
[63269926]
As the device was not returned for evaluation, we were unable to determine a root cause for the reported incident. Photographic evidence of the device was provided. Review of the photograph found no visible manufacturing issues, which is supported by the facility? S report dated 24 june 2016 which notes that? The nasal tampon was intact and neither when it was inserted, nor when it was in place did it have any technical defects?. The swallow guard and inflation tubing appears to be intact on the photos made available to arthrocare, with the balloon inflated and showing minor discoloration most likely due to blood. The instruction for use for the rr750 contains the following warning and precautionary measures to adhere to during use of the device including: during inflation, the pressure should be constantly monitored by reference to the pilot cuff. Monitor the device for any sign of deflation, which can cause dislodgement of the nasal catheter. Respiratory distress or decreased oxygenation can occur in patients at risk for impaired respiratory condition. To prevent migration/aspiration of the catheter, pilot cuff must be taped to the nose/cheek of the patient. As mentioned above, in the absence of the retrieved device, arthrocare is unable to determine the root cause for this incident. The following elements from the facility? S report dated 24 june 2016 were noted: the tape securing the device to the patient to prevent possible migration/aspiration of the catheter was removed; the facility? S report suggests that there was a lack of monitoring of the balloons pressure and that the pilot cuff was not re-inflated after prolonged (6hr) insertion in order to ensure the posterior balloon maintained sufficient pressure. The facility? S report indicates patient suffered from symptomatic severe aortic valve stenosis, cardial asthma, and other comorbid conditions no root cause related to the design or manufacture of the device could be established. We believe the ifu adequately addresses the precautions required to prevent incidents of this type. There is no impact to the devices in the field and no corrective/preventive action is deemed necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[63269927]
According to the facility? S initial report from dr. (b)(6) on 5 july 2016, a hospitalized cardiac patient was treated for a nosebleed using a rapidrhino 900 (? Rr900? ) tamponade device. It was reported to arthrocare that the patient subsequently experienced delirium (or acute confused state). During that state, he allegedly pushed the rr900 through his nose into the larynx and died due to suffocation. The emergency room team was unable to resuscitate the patient. On 15 august 2016, the facility forwarded to arthrocare a copy of their complete investigation into the incident, which clarified and corrected the original information that was provided. Specifically, the part number of the product, rr900, was initially reported in error. The corrected part number and description is rr750 (rapid rhino 7. 5cm anterior/posterior). Additionally, a detailed narrative was provided by the facility for the period of time leading up to and including the event. It was clarified that the patient was initially placed under freedom restriction measures (wrist and waist restraints, sedatives) due to delirium and an agitated state. Upon removal of the restraints, the patient apparently repeatedly fiddled and tugged at the rr750 and the tape securing the device to the nose/cheek was removed. Shortly thereafter, one side of the rapid rhino was coughed and/or blown out. During a subsequent assessment by the nurse, the patient was found agitated and standing next to the bed. It was stated that he? Fidgeted? With the rapid rhino that was on the other side and aspirated the tube with a forceful breath in. The patient quickly lost consciousness, a reanimation team was called; however, the emergency room team was unable to resuscitate the patient. The rr750 was taken out of the patient and examined by the hospital staff. The rr750 was fully intact and stated to have no technical defects. The device was disposed at the facility thus was not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2016-00168 |
| MDR Report Key | 5792312 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-07-13 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-07-05 |
| Date Added to Maude | 2016-07-13 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7.5CM ANTERIOR/POSTERIOR |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-07-13 |
| Catalog Number | RR 750 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-07-13 |