MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-03-06 for OPEN-END FLEXI-TIP URETERAL CATHETER 021304 manufactured by Cook Inc.
[101631360]
(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
[101631361]
It was reported during a cystoscopy retrograde pyelogram procedure while using the open-end flexi-tip ureteral catheter, parts of the catheter sheared off as? Chips?. Some of the chips ended up in the patient? S bladder and were removed successfully with grasping forceps. The karl storz pediatric cystoscope was looked at by the storz representative and they advised that there is a slight bend in the scope and believe this caused the shearing of the catheter. As reported, the product is not available for return and the lot number is not available. No portion of the device remained in the patient? S body. No additional procedures were required due to this occurrence. As reported, there were no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00593 |
| MDR Report Key | 7317527 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-03-06 |
| Date of Report | 2018-05-01 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-03-06 |
| 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 FLEXI-TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-03-06 |
| Catalog Number | 021304 |
| 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 | 2018-03-06 |