MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI; WIRE GUIDE

Device Problems Bent (1059); Entrapment of Device (1212); Flaked (1246); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturing batch lot was not provided therefore we were unable to review the device history records to confirm that the device met all material, assembly and inspection specifications prior to shipment.The device was received for analysis on 01/12/2017.As received, the specimen consisted of one each clinically used, damaged unidentified safari wire; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented a cut through the coil and core wires 238.35cm from the proximal end; all material distal of the cut was missing.The specimen also presented several bends/kinks of varying severity and frequency scattered over the length of the device beginning 244.7cm from the proximal aspect of the coil and core wire cut, and scraped/frayed ptfe coating scattered over the length of the device.There was no mention of the guidewire being cut in the complaint indicating it was cut in order to remove it from the lotus system.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.If additional information, or lot traceability is received a follow-up medwatch report will be filed.

Event Description

As reported: lotus stuck on wire.Device was removed stuck on safari wire.

• Brand Name: PREFORM GUIDEWIRE - SAFARI
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jackie ohnsorg ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418516
• MDR Report Key: 6260694
• MDR Text Key: 65096518
• Report Number: 2126666-2017-00004
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR