MAUDE Adverse Event Report: LAKE REGION MEDICAL THRUWAY GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number UNK591

Device Problems Bent (1059); Flaked (1246); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The batch number is unknown; therefore the manufacturing batch records for the complaint device cannot be reviewed.As received, the specimen consists of one unidentified thruway device; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents multiple kinks/bends of varying severity and frequency scattered over the length of the wire.The distal coil presents stretched coil wraps immediately distal of the proximal coil to core wire joint.The proximal marker coil presents offset/overlapping coil wraps and proximal coil to core wire joint damage, compressing the length of the marker coil and generating an oversized diameter condition.The ptfe coating presents damage including scraped, frayed and removed coating scattered from the distal coating limit to approximately 192cm from the distal tip.At this time it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors have impacted on the event as reported.A follow up medwatch report will be submitted upon completion of the device evaluation.

Event Description

The catheter stopped working midway through the procedure and another was needed to complete the case.No harm was done to the patient.On (b)(6) 2018- as per additional information received, the device folded over on itself and kinked on the wire and stopped all activity.No error message.Catheter kinked on itself.The wire and jetsteam were stuck at that point.It was an.014 x 300 thruway.The batch number of the wire wasn't saved.Both were safely removed together as a unit.Age at the time of the event: over 18 years of age.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 7610375
• MDR Text Key: 112182853
• Report Number: 2126666-2018-00039
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

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
• Device Model Number: UNK591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1