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

Model Number	M001492981
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: jetstream atherectomy case over a.014 thruway wire.The wire broke off in orient as the jetstream was being removed from the body.What troubleshooting steps, if any, resolved the issue?: tip of the wire was snared with no issue.What is the next course of action?: new wire was placed and procedure was completed patient complications: no patient complications.Additional information: question: what does the end user believe caused the thruway device to break off? answer: he believes the wires was pulled back and got stuck in calcium.Question: approximately how far from the distal tip of the thruway device did the fracture occur? answer: 1cm.Question: was fluoroscopy used during the procedure? answer: yes.Question: how were the jetstream and thruway removed from the patient? answer: the jetstream was removed normally.The fractured tip of the thruway was snared.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one 1- each 300-014 gw, long taper; returned coiled, loosed without dispenser assembly and double-bagged within "zip-lock" style poly biohazard pouches.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the manufacturing processes indicates the production operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The specimen presented a ductile tensile overload fracture of the core and coil wire with bending loads proximal of the distal coil region along with foreign material deposits.The specimen also presented multiple kink/bend damage of varying severity and frequency approximately at 99.7cm, 210cm and 288.7cm from the proximal aspect of the fracture.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) for the thruway device under the precaution section, "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." as noted in the warnings portion of the device instructions for use: ·attention should be paid to guidewire movement in the vessel.Before a wire is moved or torqued, the tip movement should be examined under fluoroscopy.Do not torque a wire without observing corresponding movement of the tip.Always advance or withdraw a wire slowly.Never push, auger, or withdraw a guidewire which meets resistance, or the guidewire may perforate the vessel if forced against resistance.Resistance may be felt tactilely or noted by tip buckling under fluoroscopy.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.No patient information was not provided.If any further relevant information is received, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• Common Device Name: 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: 17913860
• Report Number: 2126666-2023-00067
• Device Sequence Number: 12456765
• Product Code: DQX
• UDI-Device Identifier: 08714729717195
• UDI-Public: 08714729717195
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: M001492981
• Device Catalogue Number: 49-298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown