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 2017-12-01 for 0.038" HYBRID WIRE, BOX OF 5 GWH3805R manufactured by Ep Flex.
[94808100]
The device was not returned to olympus for evaluation. The cause of the event cannot be determined at this time. However, 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. " 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
[94808101]
Olympus was informed that during an unspecified procedure, as the surgeon began to withdraw the guidewire the distal end began to unravel in the patient. The user facility reported no device fragment from the guidewire or the guidewire's insulation fell inside the patient. The surgeon was able to retrieve the guidewire without intervention. The intended procedure was completed with the same guidewire. The procedure was delayed 5 minutes. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00751 |
| MDR Report Key | 7075383 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-01 |
| Date of Report | 2018-04-12 |
| Date of Event | 2017-10-27 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2017-12-01 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.038" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.038" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2017-12-01 |
| Returned To Mfg | 2018-03-01 |
| Model Number | GWH3805R |
| Catalog Number | GWH3805R |
| Lot Number | 91604399 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EP FLEX |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |