MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for GUIDEWIRE,0.035 AMPLATZ,5-UP 13BX manufactured by Lake Region Manufacturing.
[128396158]
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
[128396159]
Olympus was informed via voluntary medwatch (b)(4) that on an unknown date in (b)(6) 2018, during a cysto urethral dil complex foley catheter replacement procedure, the wire unraveled while in the patient and while the clinician was removing the wire. There was no reported patient injury. It was reported that the patient had a pre-existing bladder cancer urethral stricture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00678 |
| MDR Report Key | 8048918 |
| Date Received | 2018-11-07 |
| Date of Report | 2019-02-27 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2018-11-07 |
| 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 | RISK MANAGER |
| 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 | 2018-11-07 |
| 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 | 2018-11-07 |