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 2019-10-29 for HIWIRE NITINOL HYDROPHILIC WIRE GUIDE G30473 HW-038150 manufactured by Cook Inc.
[176664147]
Occupation: urology coordinator. 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
[176664148]
It was reported, during a ureteroscopy procedure using a hiwire nitinol hydrophilic wire guide, the coating was stripped off. The surgeon has no issue advancing the wire into the ureteroscope. When it was time to pull the wire out of the scope, the user had to forcefully pull back on the wire. This caused the nitonol to strip off from the wire. No adverse events have been reported as a result of the alleged malfunction. Additional details have been requested regarding the patient and event. At this time no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-02712 |
| MDR Report Key | 9249652 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-29 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-21 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-06-10 |
| Date Added to Maude | 2019-10-29 |
| 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 | HIWIRE NITINOL HYDROPHILIC WIRE GUIDE |
| Generic Name | OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY |
| Product Code | OCY |
| Date Received | 2019-10-29 |
| Returned To Mfg | 2019-11-05 |
| Model Number | G30473 |
| Catalog Number | HW-038150 |
| Lot Number | 11155198 |
| 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 | 2019-10-29 |