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

Lot Number	SSFA030223
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a bmc steerable sheath (sureflex) and nrg rf needle were selected for use during an ablation procedure.The tip of the nrg rf needle broke when using the rf needle.It passed through the foramen ovale without energizing, so it was completed without energizing.Additionally, when using sureflex during pre-mapping, the hemostatic valve seemed to fail or blood began to leak, thus the device was replaced.No patient complication was reported.The procedure was completed successfully.The devices are not expected to be returned for analysis.It was further informed that the nrg needle was able to cross the foramen ovale without performing energization (radio frequency was not delivered).No alert or error was reported.Since the procedure was able to be completed without energization, rf was not delivered.Additionally, the leak was identified when using sureflex during pre-mapping, blood began to leak from hemostastic valve (slow drip).It appears that the leak was coming from the hemostatic valve.No fluid was leaking from the distal or proximal end of the handle.Blood was noted leaking, which stopped using the device (sureflex).No leak air was reported.No air was seen in the patient.The flow rate was max 15ml/minute.There were no damage to the luer noted.The syringe was securely attached to the handle luer.Tool or device in place when the leak occurred was a non-boston scientific octaray 2mm space mapping catheter.A non-boston scientific octaray 2mm space mapping catheter had been inserted into the sheath prior to/during the leakage.

• 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: 18743723
• Report Number: 2124215-2024-10022
• Device Sequence Number: 20643729
• Product Code: DYB
• UDI-Device Identifier: 00685447006220
• UDI-Public: 00685447006220
• 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): 02/20/2024

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: 03/02/2024
• Device Lot Number: SSFA030223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown