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

Model Number M001492971

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Reportable based on the analysis of the returned specimen.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As received, the specimen consists of one 300-014 gw, short taper; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents several bends/kinks of varying severity and frequency scattered over the length of the device.The specimen also presents stretched and offset coil wraps distal of the distal coil proximal coil-to-core joint and scraped ptfe coating with coating removal scattered over the coated length of the device.No other damage or inconsistencies are noted to the specimen at this time.All joints appear to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct.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 initial reporter's first name is unknown.If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

This device was used but the tip part got kinked, so it was replaced with another for same device, and the procedure was performed.No patient complications and the patient condition was reported as stable.Procedure outcome: completed with another of same device - thruway.

• 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: 7412399
• MDR Text Key: 105403219
• Report Number: 2126666-2018-00025
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

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: 04/30/2020
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 10829725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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