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

Catalog Number 7371

Device Problems Bent (1059); Flaked (1246); Cut In Material (2454); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.As received, the specimen consists of one axis wire, (b)(4); returned reloaded into the dispenser assembly and placed back into the labelled mylar/tyvek packaging pouch and double-bagged within "(b)(4)" style poly pouches.The specimen presents a cut/mechanical shear of the outer coil wraps located 30.35cm from the distal tip with the coils distal of the cut shifted toward the distal tip, creating a gap in the separated coils of 0.95cm.The cut coil wraps and the exposed core wire presents toolmarks at the proximal aspect of the coil separation.The coil wraps present indications of torsional loading, in the form of overlapping offset coil wraps at the coil separation and at 18.6cm from the distal tip.The specimen also presents several bends, including a spiral bend over the distal 11.5cm, which appears to be consistent with an attempt to manually shape the distal tip.The coil wraps in the damaged coil regions, and in the spiral bend, present scraped coating with coating removal.The specimen also presents deposits of dried blood-like material on and between the coil wraps scattered over the length of the device.No other damage or inconsistencies are noted to the specimen at this time.Both 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.If any further relevant information is provided, a follow up medwatch report will be submitted.

Event Description

Physician informs me he was doing a routine catheter exchange over the wire.He was able to thread the wire through the existing catheter, but was unable to advance (deliver) the new catheter over the wire.Upon removing the wire he said it was broken.

• Brand Name: AXIS 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: 7352429
• MDR Text Key: 103066085
• Report Number: 2126666-2018-00017
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935170
• 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: 03/20/2018

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: Physician
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 7371
• Device Lot Number: 10849090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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