MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[104734987]
At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
[104734988]
Breakage of an ultratrack wire during a difficult stenting at (b)(6) by consultant (b)(6). The whole tip came off and had to be retrieved with a ureteroscope. The guidewire seems to have unravelled as it was taken out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975494-2018-00004 |
| MDR Report Key | 7397000 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-02-24 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-04-04 |
| 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 TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | STENT WIRE |
| Product Code | EYA |
| Date Received | 2018-04-04 |
| Model Number | GWH3505R |
| Lot Number | 91703832 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-04 |