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 2018-09-12 for OPEN-END URETERAL CATHETER 020015 manufactured by Cook Inc.
[119957130]
(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
[119957131]
It was reported the open-end ureteral catheter was being inserted over the wire through the scope, and did not feel "natural" to the physician. The physician took the scope out and found the catheter had snapped off clean. The patient? S anatomy was not scarred, calcified, or tortuous. The physician retrieved the broken catheter with his hand. A new catheter had to be inserted to complete the procedure. Insertion of the new catheter added an additional two minutes to the procedure. No portion of the device was left in the patient. The patient did not experience any adverse effect(s) due to this event. The patients outcome post procedure was "ok".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02617 |
| MDR Report Key | 7868508 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-05-24 |
| Date Added to Maude | 2018-09-12 |
| 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 | 2018-09-12 |
| Catalog Number | 020015 |
| Lot Number | 8907102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-09-12 |