MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Osta.
[67495734]
The device was not returned to olympus for evaluation. A review of the device history record revealed no deviations or irregularities during the manufacturing of this device. The cause of the event cannot be determined at this time. This type of guidewire damage is most likely related to the operator's technique. The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire. "do not apply excessive force to advance or withdraw the guidewire. If resistance is encountered, determine the cause and take remedial action before continuing. When using a moveable core guidewire, do not attempt to advance, stiffen or straighten the tip of the guidewire against resistance. Do not reshape or alter the configuration of the guidewire. Doing so may compromise the structural integrity of the guidewire and may result in complications. "
Patient Sequence No: 1, Text Type: N, H10
[67495735]
Olympus was informed that during an unspecified procedure, the wire began to unravel in the patient as the device was being withdrawn from the patient. The user facility reported that no fragments came off the wire or fell into patient. There was no bleeding observed. The procedure was prolonged by 5 minutes and was completed with a non olympus guidewire. There was no patient injury report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00081 |
| MDR Report Key | 6327856 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-18 |
| Date Added to Maude | 2017-02-13 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| 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 | ULTRA TRACK GUIDEWIRE |
| Product Code | EYA |
| Date Received | 2017-02-13 |
| Model Number | GWH3505R |
| Catalog Number | GWH3505R |
| Lot Number | 91605307 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |