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

Medical Device Problem Codes	Material Fragmentation (1261); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bmc steerable sheath was selected for use during an ablation.During preparation, while the device was outside the patient, the hemostatic valve at the proximal end of the hub came off (in two pieces).The surgeon reattached it and the procedure was completed.No leak was observed.During the flushing, the tubing did not fell off, nor resistance was experienced.No patient complications were reported.The device is expected to be returned 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 medwatch will be filed.
Event or Problem Description
It was reported that a bmc steerable sheath was selected for use during an ablation.During preparation, while the device was outside the patient, the hemostatic valve at the proximal end of the hub came off (in two pieces).The surgeon reattached it and the procedure was completed.No leak was observed.During the flushing, the tubing did not fell off, nor resistance was experienced.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The fields f10 and h6 (device codes (1)) were updated.Also, the returned sureflex sheath was analyzed.This is supplemental mdr to report investigation results (mdr aware date 31jan2024.) analysis of the device found during pre-decontamination the loose cap and a kinked was near rotation hub (likely due to product-return packaging).During testing, it was determined that the end cap and sheath handle were inspected under the vhx and no significant damage was observed on the valve.The outer handle and end cap had a flush mechanical connection as per design requirements.The snap fit dimension was measured and compared to the nominal specification.Specifically, the groove on both sides of the end cap were measured and which are within the nominal range.On the glue residue testing, it was noted that there was insufficient glue residue on both the sheath handle as well as end cap.For comparison, a non-complaint sheath handle was taken apart and inspected for glue residue, and a significantly higher glue residue was found on both the sheath handle and end cap.Lastly, the tensile force required to unsnap the end cap from the sheath handle was tested, and it was noted that did not meet its intended specifications.The reported allegation was confirmed (testing showed the end cap did not meet its intended specifications.

• 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: 18081394
• Report Number: 2124215-2023-61188
• Device Sequence Number: 20803214
• 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): 02/26/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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