MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-11 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630208B1 630-208B manufactured by Lake Region Medical.
[185290329]
The device was not received for evaluation at the time of this report; therefore no physical analysis of the device can be performed. A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported. The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable. As noted in the device instructions for use (dfu) warnings, "do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle. Manipulation, advancement and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval. " the dfu precautions also indicate "the zipwire hydrophilic guidewire should be advanced through the scope using short, deliberate 2-3cm movements to prevent inadvertent damage to the device or patient. " at this time, it is not possible to assign a definitive root cause for the event as reported. Based on the information provided to date, it appears that clinical and/or procedural factors have contributed to the event as report. It was reported that the patient information is not available. If there is any further relevant information received, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185290330]
It was reported that while placing stent guidewire shredded a sliver of wire off the side. Guidewire never went through bridge. Any harm to patient? No. Procedure completed successfully by opening new item: yes. Additional information received via email reported that a sliver of the polymer jacket material detached while passing the wire through the scope and that it happened before the wire had contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00018 |
| MDR Report Key | 9818165 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-11 |
| 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 | SHARON SEIFERT |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 6418518 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIPWIRE HYDROPHILIC GUIDEWIRE |
| Generic Name | UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | EZB |
| Date Received | 2020-03-11 |
| Model Number | M006630208B1 |
| Catalog Number | 630-208B |
| Lot Number | 11194298 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |