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

Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the catheter was first visually inspected, and it passed flushing test (pre and post decontamination), and the stopcock handle within specifications.Next, on the vhx testing, it was found that the sheath tip was stretched slightly on one side.The valve was also inspected, and it was just under the specification.Also, a tear was seen on the valve.Additionally, during the replication of problem, no excessive resistance was felt through the valve, hub or sheath tip when inserting the catheter through the sheath hub and valve.This was also replicated with a dilator and no issues were seen.No damage was seen on the catheter from insertion.Later, the device passed the leaking test.Therefore, the tear on the valve is not considered a risk for leakage as this was also not reported.Finally, the borescope testing was conducted on the shaft and one small defect was noted on the inside of the hub.The reported allegation of guidewire/catheter fit was not confirmed, since the issue was not able to be replicated.However, due to the damage noted to the valve, sheath tip and hub of the device, the initial mdr report is being filed.
Event or Problem Description
Reportable based on analysis completed on (b)(6)2024.It was reported that a sureflex steerable guiding sheath was selected for use for an ablation procedure indicated for a case of ventricular tachycardia (vt).During the procedure, it was mentioned that the hemostasis valve was inserted tightly, and the catheter became damaged.The procedure was still completed successfully using the original device.No patient complications were reported.Product is available for return.It has been further mentioned that the ablation catheter was not protruding out of the sheath when the issue occurred.However, the analysis of the device revealed a damage on its valve, sheath tip and hub.

• 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: 19212938
• Report Number: 2124215-2024-26047
• Device Sequence Number: 6969457
• Product Code: DYB
• UDI-Device Identifier: 00685447006237
• UDI-Public: 00685447006237
• 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): 04/30/2024

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: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/30/2024
• 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