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 2019-12-06 for HIWIRE NITINOL HYDROPHILIC WIRE GUIDE G30474 HWS-035150 manufactured by Cook Inc.
[178333022]
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
[178333023]
It was reported that during an unknown procedure, when the hiwire nitinol hydrophilic wire guide passes into an unknown ureteroscope, "it peels". This peeling then obstructs the ureteroscope making the removal harder. The material of the guidewire that peeled off was removed without issue. No adverse effects to the patient have been reported. Additional information has been requested and a follow up report will be submitted when and if that information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03025 |
| MDR Report Key | 9426442 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-12-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-07 |
| Date Added to Maude | 2019-12-06 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. 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 | 2019-12-06 |
| Returned To Mfg | 2020-02-13 |
| Model Number | G30474 |
| Catalog Number | HWS-035150 |
| Lot Number | 11170311 |
| 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 | 2019-12-06 |