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 2020-01-03 for HIWIRE NITINOL HYDROPHILIC WIRE GUIDE G30474 HWS-035150 manufactured by Cook Inc.
[178150008]
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
[178150009]
It is reported during a ureteroscopy using a hiwire nitinol hydrophilic wire guide, parts of the hydrophilic coating detached from inner core during use. No section of the device remained inside the patient, and the patient did not require any additional procedures due to this occurrence. The patient did not experience any adverse effects due to this alleged product malfunction. Additional details regarding the patient and event have been requested, at this time no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00048 |
| MDR Report Key | 9544727 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-03 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-01-03 |
| 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 | UNK JENNIFER CANADA |
| 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 | 2020-01-03 |
| Returned To Mfg | 2020-01-13 |
| Model Number | G30474 |
| Catalog Number | HWS-035150 |
| Lot Number | 11174936 |
| 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 | 2020-01-03 |