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

Lot Number	TFFC120123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bmc transseptal sheath was selected for use.During preparation of the procedure, the device was opened on sterile table and when the 3-way valve was adjusted, the handle came apart.The stopcock was being handled for the first time as it broke off and there was no resistance with the arm rotation.It was the valve itself that broke off, not the lever.A flushing was performed before use of the device, with no issue with it.No other issues were noted.Thus, a new introducer sheath was selected for use and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The returned device was analyzed.This is supplemental mdr to report investigation results (mdr aware date 10jan2024).During pre-decontamination test, it was noted that there was no resistance while maneuvering the broken stopcock.No other visible damaged noted.Flushing was successfully done pre and post decontamination.In a further testing along with digital microscope, it was further confirmed the break at the neck of the lever and revealed a minor void in the neck of the lever.While manual manipulation, the stopcock was rotated and resistance was noted.The reported allegations are confirmed based on the returned device, although in-housing testing confirmed that it was the lever that broke off the device as opposed to the "valve itself" as reported.
Event or Problem Description
It was reported that a bmc transseptal sheath was selected for use.During preparation of the procedure, the device was opened on sterile table and when the 3-way valve was adjusted, the handle came apart.The stopcock was being handled for the first time as it broke off and there was no resistance with the arm rotation.It was the valve itself that broke off, not the lever.A flushing was performed before use of the device, with no issue with it.No other issues were noted.Thus, a new introducer sheath was selected for use and the procedure was completed successfully.No patient complications were reported.The device is expected to be 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: 17826731
• Report Number: 2124215-2023-49729
• Device Sequence Number: 6069129
• Product Code: DYB
• UDI-Device Identifier: 00685447005414
• UDI-Public: 00685447005414
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/31/2024

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 Lot Number: TFFC120123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown