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

Model Number	M001492971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received for evaluation at the time of this report; therefore, no physical analysis of the product could be performed.The image provided by the distributor presented the thruway wire in two separate pieces with fractured/shear damage at an unknown distance from the distal tip.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 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.If any further relevant information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: after completing the procedure with jetstream, the thruway guide was stuck and did not leave the equipment, when the doctors were able to remove the guide, they found that the tip was broken in the same place as a piece of calcium.What troubleshooting steps, if any, resolved the issue?: n/a.What is the next course of action?: finalized the case, patient was discharged.Patient present at time of event?: yes.Patient complications: no patient complications.Was issue present upon opening package?: no.Photo or video of issue: yes.Question: how was the detached portion of the device removed (i.E.Pulled, snared etc)? answer: the doctor passed her finger and it broke.Question: please specify the approximate location of the fracture on the device? answer: at the tip.Question: was the device removed from the patient intact/fractured post procedure? answer: yes.Question: was this portion of the device outside of the body at the time of the fracture? answer: yes.

• 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: 17075637
• Report Number: 2126666-2023-00035
• Device Sequence Number: 12432189
• Product Code: DQX
• UDI-Device Identifier: 08714729717188
• UDI-Public: 08714729717188
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/06/2023

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 Expiration Date: 11/30/2025
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 7339352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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 Age: 75 YR
• Patient Sex: Male