MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	VMFC290523
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
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 during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.The guidewire was used to advanced system in the inferior vena cava (ivc) and around the pacemaker wires into the superior vena cava (svc).When the physician attempted to pull the wire out, the guidewire was stuck in the dilator.After several minutes of trying to ensure the guidewire tip doesn't get stuck around pacer wires, the dilator and the guidewire were removed and the watchman fxd curve sheath was left in to maintain the access.Once outside of the patient body, the guidewire was pushed out the distal end of the dilator and it was noted that the inner mandrel of the wire was fractured, and the guidewire was flimsy and floppy.When the staff member attempted to retract the mandrel from the back of the guidewire to straighten out, the entire distal tip of the guidewire kinked and collapsed.Hence to resolve the issue, a non-boston scientific wire was used to complete the procedure successfully.No patient complications reported.The device is not expected to be returned for analysis as it was disposed.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 17560292
• Report Number: 2124215-2023-42523
• Device Sequence Number: 3626437
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 08/16/2023

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: 08/03/2025
• Device Lot Number: VMFC290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female