MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-01-15 for ULTRATHANE PERCUTANEOUS PIGTAIL NEPHROSTOMY SET UPPN-080008-ET manufactured by Cook Inc.
[97667016]
(b)(6). (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
[97667017]
It was reported during a nephrostomy procedure, from a ultrathane percutaneous pigtail nephrostomy set, the physician realized something felt awry during the insertion of the wire guide through the puncture needle, which previously punctured the patient's kidney. The physician removed the wire guide and noticed that the wire guide had started to unravel. Another ultrathane percutaneous pigtail nephrostomy set was used to complete the procedure. No unintended portion of the device remained inside the patient? S body. No additional procedures were required due to this occurrence. No adverse effects or consequences were reported to the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00076 |
| MDR Report Key | 7191248 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-01-15 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-01-15 |
| 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 | ULTRATHANE PERCUTANEOUS PIGTAIL NEPHROSTOMY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-01-15 |
| Catalog Number | UPPN-080008-ET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-15 |