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

Model Number M001492831

Device Problems Cut In Material (2454); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2016

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 and was determined to be acceptable.Examination of the returned specimen revealed cuts by unknown means to the core wire 1.76cm from the proximal aspect of the proximal coil to core wire solder joint and 1.55cm from the proximal end of the distal coil segment; all material distal of the cuts is missing.The specimen also presents several bends of varying severity and areas of scraped ptfe coating scattered over the length of the device.Deposits of dried blood-like material are present on and between the coil wraps.No other damage or inconsistencies are noted to the specimen at this time.The proximal joint appears to be intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct.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.

Event Description

This device could not cross the lesion.The procedure was completed with jupiter tapered 45.

• 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: 5935570
• MDR Text Key: 54166830
• Report Number: 2126666-2016-00078
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: M001492831
• Device Catalogue Number: 49-283
• Device Lot Number: 10557848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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