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

Lot Number	0033572730
Medical Device Problem Codes	Flushing Problem (1252); Material Perforation (2205); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 bmc steerable sheath was selected for use for an ablation procedure.During the procedure, when attempted was made to remove an orion from the versacross sheath, the flushing port fell out.The flushing port was not pulled, but a popping sound was heard, and the base fell out from the base.The flushing was not possible to be performed.Thus, the device was replaced with another same model device and the procedure was completed successfully.No patient complication was reported.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that a sureflex bmc steerable sheath was selected for use for an ablation procedure.During the procedure, when attempted was made to remove an orion from the versacross sheath, the flushing port fell out.The flushing port was not pulled, but a popping sound was heard, and the base fell out from the base.The flushing was not possible to be performed.Thus, the device was replaced with another same model device and the procedure was completed successfully.No patient complication was reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the sureflex steerable sheath was visually inspected, and it failed; the tube side port was blocked, and the stop cock tubing was detached from sheath.Also, it showed evidence of glue residue, that there was sufficient overlap between the sideport and the tubing, and no signs of cracks or tears in the tubing.The outer diameters were below the cad dimensions.Next, the device passed the dimensional test, since the distance between hub base and tubing was within specification.Additionally, both the pull test and leakage tests passed after re-installing the tubing onto the sideport.The device was tested via a positive pressure liquid leak test.The device showed no signs of leakage.The reported allegations are confirmed.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20191133
• Report Number: 2124215-2024-56743
• Device Sequence Number: 15232101
• Product Code: DYB
• UDI-Device Identifier: 00685447006329
• UDI-Public: 00685447006329
• 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): 10/31/2024

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: 07/06/2026
• Device Lot Number: 0033572730
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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