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	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: during the procedure with jetstream after the physician removed the catheter from jet noticed that the guidewire broke inside the patient's artery, the sfa injury was treated by an open procedure and the guidewire broken in the patient was removed by the physician and the procedure was completed successfully.Medical or surgical interventions: an open surgery was performed to finalize the procedure and remove the broken guidewire in the patient.
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.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.The image provided by the distributor shows what appears to be a section of wire inside of a poly sleeve.No further evaluation can be completed based on the provided image.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
• 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: 16911667
• Report Number: 2126666-2023-00030
• Device Sequence Number: 7375255
• 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): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 5937664
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male