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

Model Number M001492981

Device Problems Entrapment of Device (1212); Flaked (1246); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the manufacturing batch record review confirmed the device met all material, assembly and inspection specifications.As received, the specimen consists of one 300-014 gw, long taper; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents numerous kinks/bends of varying severity and frequency over the length of the device; and ptfe coating damage with areas of coating removal from 41.4 to 227.5 cm from the distal tip.The proximal marker coil presents offset coil wraps and the distal coil segment presents stretched coil wraps immediately distal of the proximal coil to core solder joint.At this time it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, procedural and/or clinical factors appear to have impacted on the event as reported.If there is any further information provided, a follow up medwatch report will be submitted.

Event Description

Put the thruway wire down through the sfa and then advanced the jetstream catheter over the top of the thruway wire to begin atherectomy.They atherectomized throughout the sfa and then they take it to remove the jetstream catheter.During removal, the catheter got stuck on the thruway wire.They then had to pull the catheter and wire out and began ballooning.The catheter got stuck on the wire.They completed the atherectomy portion of the case and then he just went on with normal treatment with the balloon.No complication.Patient is fine.

• 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: 7495121
• MDR Text Key: 108176209
• Report Number: 2126666-2018-00031
• 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: 05/08/2018

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 Expiration Date: 01/31/2021
• Device Model Number: M001492981
• Device Catalogue Number: 49-298
• Device Lot Number: 10930904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR