MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.
Event or Problem Description
It was reported that the patient went into av block.During a pulmonary vein isolation procedure, a versacross connect for faradrive kit was selected for use.During placement of the faradrive and connect on the fossa ovalis, the sheath slipped anterior.The physician clicked the sheath and dilator back to the septum and the patient went into extended av block.Then, the coronary sinus catheter was moved to the ventricle to pace during procedure.The pacing rate slowly reduced until intrinsic rhythm came back.During the second attempt to place the sheath and dilator, the patient went into av block again.The physician believes, this is is due to the sheath being so large that it wants to fall anterior and the dilator so stiff that it is traumatic.The physician was able to successfully go transeptal using this product.The patient was in 2:1 block for the majority of the procedure, but their av node recovered by the case end.The patient might be kept overnight for observation.The patient might be referred for a pacemaker.The device is not expected to be returned for analysis (disposed).In the physician's opinion, the size and form of the versacross connect fitted into the faradrive sheath was the cause of the av block, the dilator/sheath system was what bumped the av node and caused block.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20578098
• Report Number: 2124215-2024-68391
• Device Sequence Number: 20833803
• Product Code: DRE
• UDI-Device Identifier: 00685447019053
• UDI-Public: 00685447019053
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K233647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown