MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. TORFLEX TRANSSEPTAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TF85-32-63-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a torflex - bmc transseptal sheath was defective.While preparing for an atrium fibrillation ablation procedure, once staff opened product on sterile table, it was noted that the sheath side port was broken, the issue was noted before the device was used in the patient.A replacement sheath was pulled to perform procedure.No other issues were noted with the preparation of the device.A replacement sheath was used to successfully complete the procedure.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
It was indicated that the device will return for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The returned product was visually inspected, and the damage described in the complaint could be confirmed by the state of the stopcock with the break in the handle component.There was no other damage noted on the returned device.No issues were found with the dhr and/or risk review.The most likely root cause for this complaint is exposure to transport conditions.
Event or Problem Description
It was reported that a torflex - bmc transseptal sheath was defective.While preparing for an atrium fibrillation ablation procedure, once staff opened product on sterile table, it was noted that the sheath side port was broken, the issue was noted before the device was used in the patient.A replacement sheath was pulled to perform procedure.No other issues were noted with the preparation of the device.A replacement sheath was used to successfully complete the procedure.No patient complications were reported.The device has been returned for analysis.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17039602
• Report Number: 2124215-2023-25917
• Device Sequence Number: 6909025
• Product Code: DYB
• UDI-Device Identifier: 00685447005414
• UDI-Public: 00685447005414
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 07/07/2023

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: 03/02/2024
• Device Model Number: TF85-32-63-90
• Device Lot Number: TFFD280722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown