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

Lot Number	SSFB310723
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have returned, and it was analyzed.Thus, an initial mdr is being filed to report the investigation results.Upon pre-decontamination of product, it was noted that the non-boston scientific libero catheter was stuck in the bard of the sheath, and it was unable to be removed.A liquid leakage test was performed with the returned non-boston scientific catheter inserted into the sheath, and a leakage was observed at its valve.The catheter was angled inside the valve which could have contributed to the leaking.Another potential reason for the leakage could be due to only the distal tip of the catheter being inserted.During post-decontamination testing, the catheter was removed from the sheath and a liquid leakage test was performed again on the sheath, and it passed specifications, since no leakage was observed on the sheath, which worked as expected, and no damage to it was noted.Also, during the borescope inspection inside the sheath noted a lip formation on the barb (entrance of side port tubing).The lip did not detach from the hub, therefore there is no concern about it.The reported allegation is not confirmed.The device returned (sureflex sheath) did not get kink.The non-boston scientific catheter that was inserted inside the sheath got stuck upon retraction.
Event or Problem Description
It was reported during a procedure, a sureflex steerable guiding sheath was selected for use.During the withdrawal/closure time of event, the device was difficult to insert and got kinked.A non-boston scientific catheter (japan lifeline's ring catheter libero 20p 15mm) was inserted into the sureflex and used, and when an attempt was made to remove the ring catheter, it got stuck, and it could not be moved at all.Hence, to resolve the issue, another device was used and the procedure was completed successfully.No patient complications occurred.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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18977078
• Report Number: 2124215-2024-17535
• Device Sequence Number: 12404975
• 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
• 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: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown