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

Model Number M001492831

Device Problems Entrapment of Device (1212); Flaked (1246); Material Integrity Problem (2978)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not received at the time of this report; therefore, no physical analysis of the device can be performed.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.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.If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

The lesion was able to cross with a thruway in a crossover approach for an sfa case and pre-dilation was performed with a 4mm and then the device was delivered since post-dilation was performed with a sterling after an eluvia 6mm 120mm and 7mm 120mm were placed, but the resistance became severe when the balloon started to come out from the tip of the parent, and it could not be delivered smoothly into the stent.Delivery was performed while resistance was felt in the stent and inflation of the balloon was performed about 3 times and the balloon was tried to be removed, but the balloon got stuck with the guide wire and it could not be removed, so it was removed as a set with the guidewire.After that, imaging was performed, and the procedure was completed.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each 300-018 short taper guidewire.Returned lodged within the sterling catheter, coiled, loose and double bagged within "zip-lock" style poly biohazard pouches.The thruway device was lodged within the sterling catheter with the distal 83.4cm of the thruway device extending distally from the catheter and the proximal 48.85cm of the thruway device extending from the proximal luer hub of the catheter.The thruway device presented bends/kink of varying severity and frequency from the distal tip to 295cm from the distal tip.The thruway device also presented random areas of scraped ptfe coating with coating removal, exposing the metallic core wire scattered over the distal 68cm.The 160.2cm working length of the sterling catheter presented extensive accordion damage to the inner and outer lumen creating extensive constraint on the thruway wire.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.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.If any further relevant information is received, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11372912
• MDR Text Key: 233323924
• Report Number: 2126666-2021-00005
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729405627
• UDI-Public: 08714729405627
• Combination Product (y/n): N
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: 08/31/2023
• Device Model Number: M001492831
• Device Catalogue Number: 49-283
• Device Lot Number: 5907498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1