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 2018-04-09 for OPEN-END URETERAL CATHETER 020015 manufactured by Cook Inc.
[105374884]
(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
[105374885]
It was reported that the open-end ureteral catheter was dry and kinked and then broke into two pieces when being inserted into the patient during a ureteral catheter placement procedure. One piece stayed inside and had to be removed. A second catheter was then used but the same incident occurred. The second catheter that broke was from the same lot number. Both catheters broke into two pieces and were fully removed from the patient. As reported, no section of the device was retained by the patient. There were no adverse consequences to the patient as a result of this reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00946 |
| MDR Report Key | 7406163 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-09 |
| Date of Report | 2018-05-29 |
| Date Mfgr Received | 2018-05-23 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-04-09 |
| 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 | OPEN-END URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-04-09 |
| Catalog Number | 020015 |
| 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 | 1. Required No Informationntervention | 2018-04-09 |