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

Model Number	TSK0005
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure a sureflex steerable guiding sheath was selected for use.The joint between the sheath and dilator peeled off during a puncture attempt and puncture was not possible.The sheath was replaced with another of the same model and the procedure was completed.No patient complications were reported.The device is not expected to be returned for analysis.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 16860138
• Report Number: 2124215-2023-16440
• Device Sequence Number: 17631861
• Product Code: DYB
• UDI-Device Identifier: 00685447006220
• UDI-Public: 00685447006220
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: TSK0005
• Device Lot Number: SSFA041122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown