MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[107088385]
The device has been discarded by the facility. 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. Device was discarded.
Patient Sequence No: 1, Text Type: N, H10
[107088386]
Boston scientific stent placed over ultratrack guidewire. During insertion, floppy distal tip of guidewire broke off and was left inside patient. Guidewire and stent removed and wire frayed. Distal tip left in patient removed separately after by doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975494-2018-00005 |
| MDR Report Key | 7455171 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Date Added to Maude | 2018-04-24 |
| 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 | GUIDEWIRE |
| Product Code | EYA |
| Date Received | 2018-04-24 |
| Model Number | GWH3505R |
| Lot Number | 91702106 |
| ID Number | UDI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-24 |