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

Model Number	TSK0004
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a pulmonary vein isolation procedure, a sureflex steerable guiding sheath was selected for use.The ablation catheter was not displayed on the 3-d display.An attempt was made to replace the catheter by removing it from the sheath.Aspiration was performed from the three-way live wire of the sheath, and when it was released, air was drawn in from the port toward the tip of the sheath.Upon noticing the abnormality, the three-way live wire was immediately turned off, and the drawn-in air was aspirated with a syringe.The sheath was then removed from the body.An echo showed no problems with cardiac function, and no changes were confirmed in the electrocardiogram.In the physician opinion, the shaft of the sheath got kinked causing negative pressure inside the sheath when the ablation catheter was removed, which could have caused air to be drawn in when the three-way wire was released.Later, the procedure was cancelled due to another reason.The device is expected to be returned for analysis.The procedure was not cancelled due to device, as this was a case of atrial fibrillation redo and pulmonary vein isolation had been achieved, the procedure was discontinued for safety reasons.There were no changes in cardiac function were observed on ecg or echo.The case used the original device.The stopcock valve was closed during the exchange.
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 device was returned for analysis.The device was flushed, no damage to valve and slit appears within specification.Air leakage testing passed with nothing inserted through valve, and using a mandrel and thermocool catheter inserted through valve.There was kink along distal section and tip damage observed.Analysis of the device found the reported allegations related to leakage are not confirmed as device passed air leakage testing.The reported allegation related to kink is confirmed.
Event or Problem Description
It was reported during a pulmonary vein isolation procedure, a sureflex steerable guiding sheath was selected for use.The ablation catheter was not displayed on the 3-d display.An attempt was made to replace the catheter by removing it from the sheath.Aspiration was performed from the three-way live wire of the sheath, and when it was released, air was drawn in from the port toward the tip of the sheath.Upon noticing the abnormality, the three-way live wire was immediately turned off, and the drawn-in air was aspirated with a syringe.The sheath was then removed from the body.An echo showed no problems with cardiac function, and no changes were confirmed in the electrocardiogram.In the physician opinion, the shaft of the sheath got kinked causing negative pressure inside the sheath when the ablation catheter was removed, which could have caused air to be drawn in when the three-way wire was released.Later, the procedure was cancelled due to another reason.The device is expected to be returned for analysis.The procedure was not cancelled due to device, as this was a case of atrial fibrillation redo and pulmonary vein isolation had been achieved, the procedure was discontinued for safety reasons.There were no changes in cardiac function were observed on ecg or echo.The case used the original device.The stopcock valve was closed during the exchange.The device was 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): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21148325
• Report Number: 2124215-2024-83886
• Device Sequence Number: 18474178
• Product Code: DYB
• UDI-Device Identifier: 00685447005643
• UDI-Public: 00685447005643
• 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): 03/20/2025

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 Expiration Date: 07/06/2026
• Device Model Number: TSK0004
• Device Catalogue Number: TSK0004
• Device Lot Number: 0033722174
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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