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

Model Number M001492971

Device Problems Flaked (1246); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

This medwatch report is being filed based on the analysis of the returned specimen exhibiting ptfe coating damage and removal.As received, the specimen consisted of one-1 each 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.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 numerous bends/kinks of varying severity and frequency scattered over the length of the device.The specimen also presented ptfe coating damage, including scraped, frayed and coating removal, 36.5 to 47.5cm from the distal tip and scattered proximally.The first distal marker coil and the proximal marker coil presented offset coil wraps.The distal coil presented stretched coil wraps distal of the proximal coil to core wire joint.The second distal marker coil is stretched distally due to its distal joint failure.All remaining joints appeared to be intact and present.The damage presented appeared consistent with manipulation of the wire against resistance.As there was no mention of coating damage in the complaint documentation, it is likely that the coating damage was incurred while separating the specimen wire from the jetstream catheter at the distributor.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), "free movement of the guidewire within the catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information.Test the system for any resistance prior to use." 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 available at the time of this report.If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

Event description: it was reported that: device issues or patient complications? only device performance issue(s) description of the event: jetstream and wire fractured together.No serious injury.The patient was treated with another device; patient's condition is good what troubleshooting steps took place? yes what troubleshooting steps, if any, resolved the issue? what is the next course of action? the wire was returned along with the jetstream 1.6mm; no serious injury for the patient.

• 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: 12349286
• MDR Text Key: 267658336
• Report Number: 2126666-2021-00036
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729717188
• UDI-Public: 08714729717188
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/20/2021

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: 07/31/2023
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 5907500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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