MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-05 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222B manufactured by Lake Region Medical.
[185701406]
The device was not received for evaluation; 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 indicated in the operational instructions section of the device instructions for use, "before removing the zipwire hydrophilic guidewire from the protective hoop (by its distal end), inject physiological saline solution into the hub end of the holder in order to completely wet the surface of the wire. " based on the information received to date, it is not possible to assign a definitive root cause for the event as reported. If there is any further relevant information received, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185701407]
Event description: per cnf: it was reported that the physician unpacked the device, activated the hydrophilic coating and found that it was fractured after pulling out a part. Then the physician pulled out the device again, but it was fractured as well. The device is expected to be returned before feb. 06th. There were no patient complications reported. Additional information: what was the patient condition following procedure? Stable was the problem associated with labeled use? Yes how was the procedure completed? Completed with a different device it was reported product is not available to return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00006 |
| MDR Report Key | 9671097 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2020-02-05 |
| 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 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9526418518 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| 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 | 2020-02-05 |
| Model Number | M006630222B1 |
| Catalog Number | 630-222B |
| Lot Number | 11132991 |
| 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 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |