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

Model Number M001492971

Device Problems Break (1069); Entrapment of Device (1212); Flaked (1246); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: 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.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.The specimen presents a fracture of the core wire shaft 93.95cm from the distal tip with tool marks and wire material removal 0.5cm distal and 0.05cm proximal of the fracture.The specimen also presents ptfe coating damage and removal scattered over the coated length of the wire shaft, with the most noticeable ptfe coating damage and removal from 12.5cm distal and 6.95cm proximal of the fracture.The specimen also presents numerous kinks/bends of varying severity and frequency from the distal tip to 5.5cm from the proximal end.The distal coil presents 1.2mm of stretched coil wraps immediately distal of the proximal coil to core wire joint in addition to biomaterial adhered to the proximal coil to core wire joint.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.As noted in the device instructions for use (dfu) precautions, "do not torque, advance or withdraw the wire if significant resistance is felt, torquing, advancing or withdrawing a guidewire against significant resistance may cause vessel damage, guidewire damage and/or guidewire tip separation." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appears that clinical and/or procedural factors have contributed to the event as reported.If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

It was reported that at the end of the case, when they were just about to finish spinning, the wire and the device got stuck together.The guidewire jammed.The procedure has good result.It was fine.The procedure was completed.Patient is fine.No complications.They got stuck when it was still inside of the patient's body.

• 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: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 8387784
• MDR Text Key: 139343288
• Report Number: 2126666-2019-00013
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2019

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: 09/30/2021
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 11057753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• 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
• Patient Age: 63 YR