MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC PROTRACK PIGTAIL WIRE; WIRE, GUIDE, CATHETER

Model Number	PTW-25-230
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a protrack pigtail wire was selected for use during a transcatheter aortic valve replacement (tavr).Prior to the procedure, the wire was handed off and upon opening packaging the wire was kinked, and it was noticed that pigtail shape was unraveled.Hence, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis (retained by customer).
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The device was not returned and hence the reported allegation could not be confirmed.However, as per the label review and based on the information provided it appeared that handling factors have contributed to the event as reported.The investigation findings do not lead to a clear root case about the reported allegation.
Event or Problem Description
It was reported that a protrack pigtail wire was selected for use during a transcatheter aortic valve replacement (tavr).Prior to the procedure, the wire was handed off and upon opening packaging the wire was kinked, and it was noticed that pigtail shape was unraveled.Hence, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis (retained by customer).

• Brand Name: PROTRACK PIGTAIL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): LAKE REGION MEDICAL INC; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20615526
• Report Number: 2124215-2024-69565
• Device Sequence Number: 15658734
• Product Code: DQX
• UDI-Device Identifier: 00685447001010
• UDI-Public: 00685447001010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: PTW-25-230
• Device Catalogue Number: PTW-25-230
• Device Lot Number: 0008872674
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown