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 2019-05-15 for PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET G14095 080010 manufactured by Cook Inc.
[145511052]
The investigation is in progress. A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[145511053]
It was initially reported on 19mar2019, the reporter is declaring a defect with the percutaneous pigtail nephrostomy set. During percutaneous placement of a drain in the renal pelvis of a urinoma the wire guide got stuck inside the dilator. Despite requests for additional patient and event details, no further information has been provided. On 15apr2019, during analysis of the returned 10fr pigtail catheter and. 038" teflon coated wire guide, it was observed that the guide is unraveled and the safety wire is broken. Based upon the condition of the returned device, this event has been determined to be a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01165 |
| MDR Report Key | 8612079 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-12 |
| Date of Event | 2017-10-14 |
| Date Mfgr Received | 2019-05-17 |
| Device Manufacturer Date | 2017-02-13 |
| Date Added to Maude | 2019-05-15 |
| 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 |
| 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 | PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-04-02 |
| Model Number | G14095 |
| Catalog Number | 080010 |
| Lot Number | 7670729 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-05-15 |