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

Model Number	TSK85-32-BD-71S
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
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 a bmc steerable sheath - sureflex was selected for use during a pulmonary vein isolation for atrial fibrillation.During isolation of the right pulmonary vein, it was found that the side port was separated/detached from the hub handle (separated in two pieces).There was no sign of torsion, and the adhesive part had come loose.Thus, a second device of the same lot was used to complete the procedure.No other issue was noted.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
During analysis of the returned device (21aug2023), it has been confirmed the separation of the side port tubing from the hub.The device appeared to be within specification: after re-attaching the tubing to the hub, the device passed leakage testing and tensile showed that the device was expected to have met it's joint strength requirements prior to the initial separation.The most likely mechanism suspected to have lead to the tubing detachment was excessive force on the tubing during use.The field b5 - describe event or problem- was updated.
Event or Problem Description
It was reported that a bmc steerable sheath - sureflex was selected for use during a pulmonary vein isolation for atrial fibrillation.During isolation of the right pulmonary vein, it was found that the side port was separated/detached from the hub handle (separated in two pieces).There was no sign of torsion, and the adhesive part had come loose.Thus, a second device of the same lot was used to complete the procedure.No other issue was noted.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.It was further confirmed by the analysis of the returned device (21aug2023) the separation of the side port tubing from the hub.

• Brand Name: SUREFLEX STEERABLE 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: 17347067
• Report Number: 2124215-2023-37621
• Device Sequence Number: 6912825
• Product Code: DYB
• UDI-Device Identifier: 00685447006305
• UDI-Public: 00685447006305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190688
• 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): 09/14/2023

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: TSK85-32-BD-71S
• Device Lot Number: SSFF030123
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown