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

Model Number	TORFLEX 8.5F 63CM 45DEG
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
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.
Event or Problem Description
It was reported that during the preparation of an ablation procedure to treat tachycardia, a torflex transseptal guiding sheath was selected for use.The sheath was opened on sterile table and once the valve was adjusted, the handle broke off.The stopcock was being handled for the first time when it broke off.There was no resistance experienced with the arm rotation and the valve itself broke off.Hence to resolve the issue, a new sheath was used and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Supplemental report is being submitted for the investigation results (mdr aware date 10jan2024).The returned device was analyzed.During pre-decontamination test, it was noted that there was no resistance while maneuvering the broken stopcock.Flushing was successfully done and no other visible damaged noted.The vhx imaging testing confirming a break at the neck of the lever.During the manual manipulation, the stopcock was rotated and resistance was noted.It is not suspected that the resistance noted during rotation is the root cause as the same stopcock component is also used in various products.The reported allegation is 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 during the preparation of an ablation procedure to treat tachycardia, a torflex transseptal guiding sheath was selected for use.The sheath was opened on sterile table and once the valve was adjusted, the handle broke off.The stopcock was being handled for the first time when it broke off.There was no resistance experienced with the arm rotation and the valve itself broke off.Hence to resolve the issue, a new sheath was used and the procedure was completed successfully.No patient complications occurred.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, qc 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: 17827751
• Report Number: 2124215-2023-51413
• Device Sequence Number: 20384806
• Product Code: DYB
• UDI-Device Identifier: 00685447005391
• UDI-Public: 00685447005391
• 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): 01/11/2024

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: 02/05/2026
• Device Model Number: TORFLEX 8.5F 63CM 45DEG
• Device Lot Number: TFFD120623
• 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: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown