MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[132066937]
The device was not returned to olympus for evaluation. In addition, insufficient information was provided by the user facility. Multiple follow ups were made by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The cause of the reported event cannot be determined at this time. However, the instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire: "inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. Carefully and slowly withdraw the guidewire from the patient to avoid any damage. The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking. If this occurs, it is recommended that any fragments of the outer coating material be removed. While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.?
Patient Sequence No: 1, Text Type: N, H10
[132066938]
Olympus was informed that during a procedure, the doctor had inserted the device into the patient? S kidney and when the doctor went to remove the device it could not be removed. The doctor had to remove the entire stent and then the device became? Unraveled?. The doctor used a second device from the same lot and the second device also failed as well. The procedure was completed using a non-olympus device. There was no injury reported. 2 of 2 devices
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00317 |
| MDR Report Key | 8210715 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-05-21 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 4089355124 |
| 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 | GUIDE WIRE, HYBRID |
| Product Code | EYA |
| Date Received | 2019-01-02 |
| Returned To Mfg | 2019-01-21 |
| Model Number | GWH3505R |
| Lot Number | 91706356 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-02 |