MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-05 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222B manufactured by Lake Region Medical.
[185291165]
Device evaluation: if any further relevant information is received, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185291166]
It was reported that the physician unpacked the guidewire. When the physician advanced the guidewire into the patient's body, it was found some part of the guidewire had no hydrophilic coating, it could not be used. The device is expected to be returned before feb. 3rd. There were no patient complications reported. The procedure was completed with a different device (same model).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00017 |
| MDR Report Key | 9794625 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2020-03-05 |
| 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 |
| 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 | 2020-03-05 |
| Returned To Mfg | 2020-02-28 |
| Model Number | M006630222B1 |
| Catalog Number | 630-222B |
| Lot Number | 11132991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-05 |