MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-22 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[93571171]
The user facility discarded the device after the procedure; therefore, no evaluation will be performed. 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
[93571172]
Olympus was informed that during an unspecified procedure, while the surgeon was inserting the stent the guidewire broke and began to uncoil in the patient. It was reported that no device fragment fell into the patient. The surgeon was able to retrieve the guidewire. The intended procedure was completed with the same guidewire. The procedure was not delayed. The patient was discharge in stable condition. Additionally, the guidewire was inspected prior to the procedure with no anomalies found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00742 |
| MDR Report Key | 7052792 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-11-02 |
| Date Added to Maude | 2017-11-22 |
| 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 | 3 |
| Brand Name | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.035" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2017-11-22 |
| Model Number | GWH3505R |
| Catalog Number | GWH3505R |
| Lot Number | UNKNWON |
| ID Number | UDI |
| 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 | 2017-11-22 |