MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-13 for OPEN-END URETERAL CATHETER 020013 manufactured by Cook Inc.
[138802498]
Concomitant medical products: 6fr pediatric scope, wire guide, 4fr stent. Occupation: other healthcare professional. Pma/510k #? Exempt pre-amendment. (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
[138802499]
It is reported during a cystoscopy with retrogrades using a 6fr pediatric cystoscope and a cook open-end ureteral catheter, several pieces of the ureteral catheter broke off in the bladder. The surgeon was able to retrieve all of the pieces during the same procedure using graspers. After removing the pieces, the surgeon placed a wire guide, then placed a 4fr stent with fluoro and injected to complete the procedure. The patient experienced no adverse effects as a result of this alleged product malfunction. Additional patient specific details were requested, however the complaint facility stated that they could not release patient specific information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00654 |
| MDR Report Key | 8417510 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-13 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2016-09-15 |
| Date Added to Maude | 2019-03-13 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN-END URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-03-13 |
| Catalog Number | 020013 |
| Lot Number | 7275576 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-13 |