MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC SUREFLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TSK0005
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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 a sureflex steerable guiding sheath was selected for use during an ablation procedure.During the procedure, appearance of air has occurred, while inserting the non-boston scientific catheter (beeat).The air was observed to be in the syringe.No air was observed within the sheath when the dilator was removed from it.The suction was confirmed.When the sheath and catheter were inserted, suction was performed from the side port, the air was able to be removed, so a replacement of the sheath was performed.The procedure was completed successfully.No patient complications were reported.The product is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the sureflex sheath was visually inspected, and no damage was noted to its valve or sideport systems.The leaking test was unable to be performed, due to material in the sideport tubing.Additionally, no damage noted via vhx upon inspecting valve, sideport joint, tubing or stopcock.Therefore, the reported allegation was not confirmed.Farther, no damage was noted that could lead to air leakage.
Event or Problem Description
It was reported that a sureflex steerable guiding sheath was selected for use during an ablation procedure.During the procedure, appearance of air has occurred, while inserting the non-boston scientific catheter (beeat).The air was observed to be in the syringe.No air was observed within the sheath when the dilator was removed from it.The suction was confirmed.When the sheath and catheter were inserted, suction was performed from the side port, the air was able to be removed, so a replacement of the sheath was performed.The procedure was completed successfully.No patient complications were reported.The product is expected to be returned for analysis.

• Brand Name: SUREFLEX STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21118435
• Report Number: 2124215-2024-83427
• Device Sequence Number: 12628341
• Product Code: DYB
• UDI-Device Identifier: 00685447005650
• UDI-Public: 00685447005650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: TSK0005
• Device Catalogue Number: TSK0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown