MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for 0.038" HYBRID WIRE, BOX OF 5 GWH3805R manufactured by Ep Flex.
[129174579]
The user facility discarded the device after the procedure; however, the original equipment manufacturer (oem) did review photographic images of the subject device provided by the customer. Based on the photographic investigation, the most likely cause for the guidewire damage is excessive force applied during use. 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. " furthermore, the oem performed a review of the device history record (dhr) for the subject device and lot number. There were no nonconformities noted during the manufacturing of this device. Since the customer? S device was not returned no further root cause analysis could be performed.
Patient Sequence No: 1, Text Type: N, H10
[129174580]
Olympus was informed that during a therapeutic urethroscopy procedure, the coating from the guidewire came off, while being used in several areas inside the patient. It was reported that the device fragments were not retrieved as they were no longer visible, when the coating was noted to be missing. The guidewire reportedly had come in contact with a stone in the patient? S ureter. The surgeon noted that the guidewire formed a loop at the distal tip which created a knot. The guidewire was manipulated and surgeon was able to retrieve the guidewire without issue. The intended procedure was completed with the same device. There was no patient injury reported. Additionally, the user facility reported that the guidewire was inspected prior to use with abnormalities found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00703 |
| MDR Report Key | 8072129 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-14 |
| 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 | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 0.038" HYBRID WIRE, BOX OF 5 |
| Generic Name | 0.038" HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2018-11-14 |
| Model Number | GWH3805R |
| Catalog Number | GWH3805R |
| Lot Number | 91802491 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EP FLEX |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |