MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for GUIDEWIRE,0.035 AMPLATZ,5-UP 13BX manufactured by Lake Region Manufacturing.
[125769069]
The device has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To avoid injury to the patient, the device instructions for use document recommends? Do not apply excessive force to advance or withdraw the guidewire. Doing so may result in complications. If resistance is encountered, determine the cause and take remedial action before continuing.? As a preventive measure against device damage, the instructions for use warn? 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.? And? 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.? Prior to use, the instructions for use also state that the device should be stored in a dark, cool, dry place.
Patient Sequence No: 1, Text Type: N, H10
[125769070]
Olympus was informed that during an unspecified urologic procedure, the clinician sensed resistance in moving the guidewire up the ureter. It was noticed that the guidewire had begun to unravel at the tip while in the patient. The guidewire was withdrawn from the patient and through the endoscope. There was no reported patient injury, and no report of any fragment missing or fallen into the patient. When the guidewire was removed from the endoscope, an approximate foot and a half length of wrapping wire unraveled from the core at the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00612 |
| MDR Report Key | 7963242 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-10-12 |
| 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 | GUIDEWIRE,0.035 AMPLATZ,5-UP |
| Generic Name | STYLET, URETERAL |
| Product Code | EYA |
| Date Received | 2018-10-12 |
| Model Number | 13BX |
| Catalog Number | 13BX |
| Lot Number | 11021391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MANUFACTURING |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-12 |