MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-13 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630205B1 630-205B manufactured by Lake Region Medical.
[183374105]
The device was not received for evaluation and was reported to have been disposed; therefore no physical analysis of the device can be performed. The lot number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed. As noted in the device instructions for use (dfu) warnings, "use extreme caution when using a laser, making sure to avoid contact with the zipwire hydrophilic guidewire. Direct contact may cause damage to the wire and/or sever the wire. " at this time, it is not possible to assign a definitive root cause for the event as reported. Based on the information provided, clinical and/or procedural factors appear to have impacted on the event as reported. The patient information was not provided at the time of this report. If there is any further relevant information provided, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183374106]
Event description: it was reported that the physician severed the wire with the laser. He cut the wire in half accidentally. The case was cancelled and went to another procedure to go through the patient's back and retrieve the wire. Was the wire successfully retrieved? Yes, during the rescheduled case. No patient complications noted but they had to go to another procedure. There is no visible damage on the packaging this is inside the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00019 |
| MDR Report Key | 9829012 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | M006630205B1 |
| Catalog Number | 630-205B |
| 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 | 1. Required No Informationntervention | 2020-03-13 |