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

Lot Number	SSFA050723
Medical Device Problem Codes	Flushing Problem (1252); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
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 for an ablation procedure.During preparation, while the device was outside the patient, it was mentioned that the base of the flushing port got separated from the sheath handle.The flushing was impossible to perform due to the damage that occurred.The user does not believe it got damaged during removal.The device was replaced (different device, same model), and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the sureflex steerable guiding sheath was first visually inspected; the stopcock valve came detached from the tube, and once it was reattached to the rest of the device to be flushed, flushing was successful.The stopcock was easily removed as there is no glue to hold it.During the dimensional analysis, the components were inspected for glue residue under the vhx; it was noted that there was glue residue present on the side port tubing outer surface and the stopcock male luer slip inner surface, however, the exact volume of glue applied on these components cannot be quantified.Later, the dimensional testing revealed that the stopcock inner diameter, tubing outer diameter and length were within specifications.Therefore, the reported allegation of detached sideport tubing was confirmed since the sheath was returned for analysis and testing showed the 3-way stopcock was detached from the sideport tubing.
Event or Problem Description
It was reported that a sureflex steerable guiding sheath was selected for use for an ablation procedure.During preparation, while the device was outside the patient, it was mentioned that the base of the flushing port got separated from the sheath handle.The flushing was impossible to perform due to the damage that occurred.The user does not believe it got damaged during removal.The device was replaced (different device, same model), and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19669180
• Report Number: 2124215-2024-41179
• Device Sequence Number: 15182765
• Product Code: DYB
• UDI-Device Identifier: 00685447006213
• UDI-Public: 00685447006213
• 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): 09/25/2024

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: 07/12/2025
• Device Lot Number: SSFA050723
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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