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

Lot Number	SSFB310723
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use for a pulmonary vein isolation indicated for a case of atrial flutter (af).During the procedure, the physician mentioned that when the catheter was removed from the sheath and flushing was attempted, a piece of the sideport broke off and the sideport tube became separated from the handle.The event occurred outside of the patient and no patient complications reported.Procedure completed successfully using a different device, same model.Product is expected to return for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental will be filed.
Additional Manufacturer Narrative
The device has been received for analysis.During analysis, the device passed pre and post decontamination.In the course of the visual inspection, it was found that the stopcock handle was not broken or missing, no visible signs of cracking near the valve, handle was not difficult to twist for the first time and was also smooth afterwards, stopcock tube was detached.Also, after removing the sideport again, vhx testing of the tubing and sideport revealed that the tubing had a ridge (indicating that it did initially overlap the sideport), as well as the presence of uv glue.No voids or tears were observed on the tubing.The sideport had a change in texture, confirmed to be due to the glue.The device passed the leakage testing when sideport was reattached.The device was then subject to tensile testing and passed.Lastly, concurrent pressure and pulling testing was performed.This testing identified that it was possible to pull off the sideport by rotating the tubing in different directions while pressure was applied (flushing simulation).The same motion was replicated on non-returned sheaths with glue and was not possible to recreate.The reported allegation is confirmed.Also, the fields b5 (describe event or problem), b7 (other relevant history), f10, h6 (device codes (1)), and g2 (report source (other)) were updated.Thus, this supplemental mdr is being field for the correction and investigation results.
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use for a pulmonary vein isolation indicated for a case of atrial flutter (af).During the procedure, the physician mentioned that when the catheter was removed from the sheath and flushing was attempted, a piece of the sideport broke off and the sideport tube became separated from the handle.The event occurred outside of the patient and no patient complications reported.Procedure completed successfully using a different device, same model.Product is expected to return for analysis.
Additional Manufacturer Narrative
The field b5 (describe event or problem) was updated.Thus, this supplemental mdr is being filed for the correction.
Event or Problem Description
It has been reported that a sureflex steerable guiding sheath was selected for use for a pulmonary vein isolation indicated for a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that when the catheter was removed from the sheath and flushing was attempted, a piece of the sideport broke off and the sideport tube became separated from the handle.The event occurred outside of the patient and no patient complications reported.Procedure completed successfully using a different device, same model.Product is expected to return 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18547023
• Report Number: 2124215-2024-02687
• Device Sequence Number: 21064243
• 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,Followup
• Report Date (Section B): 03/26/2024

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: 08/03/2025
• Device Lot Number: SSFB310723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 02/26/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/13/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown