MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-19 for BANDER URETERAL DIVERSION STENT SET 025807 manufactured by Cook Inc.
[103273313]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[103273314]
It was reported during a cystectomy procedure, the wire guide that comes with the bander ureteral diversion stent was placed in the patient? S ureter through the conduit and was clipped at one end. When the surgeon attempted to pull the wire out, the wire? S core came out and the outer casing began to completely unravel during removal. The wire tip was separated from the core of the wire but was attached by the outer wire casing. All of the wire eventually came out but there was a lot of friction. It was reported no section of the device remained inside the patient. No additional procedures were required as a result of this issue. There were no adverse effects to the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00692 |
| MDR Report Key | 7350131 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-19 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-03-19 |
| 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. 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 | BANDER URETERAL DIVERSION STENT SET |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-03-19 |
| Catalog Number | 025807 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-03-19 |