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

Model Number	TSK85-32-BD-71S
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use.During the procedure, the physician mentioned that they were unable to aspirate fluid through the device after 1 hour of use inside the patient.The sheath was then removed and replaced; procedure was completed successfully.No patient complications were reported.Product is not expected to return for analysis (disposed).
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.
Additional Manufacturer Narrative
Due to additional information received, this report is being submitter for the updates on the initial mdr in block describe event or problem (b5), in section b - adverse event/product prob.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.
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use.During the procedure, the physician mentioned that they were unable to aspirate fluid through the device after 1 hour of use inside the patient.The sheath was then removed and replaced; procedure was completed successfully.No patient complications were reported.Product is not expected to return for analysis (disposed).It has been further mentioned that no other devices where inside the sheath when the issue was noted.No damage was noted on the device when it was removed.However, a piece of tissue was found on the tip of the catheter.

• 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: 21548843
• Report Number: 2124215-2025-14236
• Device Sequence Number: 4402159
• Product Code: DYB
• UDI-Device Identifier: 00685447005797
• UDI-Public: 00685447005797
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/25/2025

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: TSK85-32-BD-71S
• Device Catalogue Number: TSK85-32-BD-71S
• Device Lot Number: 0035388891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown