MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[109771314]
The customer's complaint of the guidewire unraveling could not be confirmed since the device was discarded at the user facility and was not returned to olympus for evaluation. Therefore, due to the lack of information, the root cause cannot be determined. 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
[109771315]
The customer had two ultratrack wires unravel during one case. Once inside the patient and the other putting it inside the patient. The customer discarded the wires so we do not have any product information see complaint# (b)(4) for the first device used in the same procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975494-2018-00008 |
| MDR Report Key | 7556875 |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-05-09 |
| Date Added to Maude | 2018-05-31 |
| 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 | 5088042739 |
| 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 | WIRE |
| Product Code | EYA |
| Date Received | 2018-05-31 |
| Model Number | GWH3505R |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 72581 GM 72581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |