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

Model Number M001492971

Device Problems Flaked (1246); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one 300-014 gw, short taper guidewire; 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.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The specimen presented multiple kinks/bends of varying severity and frequency scattered over the length of the specimen.The specimen also presented scraped/frayed ptfe coating in a proximal to distal orientation, with coating removal and loose ptfe, scattered over the coated length.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.The damage presented by the specimen appears consistent with manipulation against resistance.As noted in the precautions portion of the thruway device instructions for use, "do not torque, advance or withdraw the guidewire if significant resistance is felt.Torqueing, 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, it appears that clinical and/or procedural factors have contributed to the event as reported.The patient information was not provided at the time of this report.If there is any further relevant information provided, a follow up medwatch report will be filed.

Event Description

Event description: it was reported that: the wire was delaminated.It was noticed when it was already in the patient's body.No complications to the patient.A new wire of same kind was used to complete the procedure.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, mn ; 6418518
• MDR Report Key: 9722248
• MDR Text Key: 185292390
• Report Number: 2126666-2020-00016
• 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: 02/18/2020

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: 09/30/2022
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 11177015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2019
• 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