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

Lot Number	VMFE290523
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a versacross connect laac access solution kit was selected for use for a watchman left atrial appendage closure (laac) procedure.The physician normally uses the versacross rf wire as a starter wire.However, this patient had pacemaker leads, and it was decided to advance with the mechanical guidewire.After the wire was anchored into the superior vena cava (svc), the physician advanced the connect dilator and watchman sheath up to the svc.The mechanical guidewire got stuck in the dilator when he attempted to retract the wire out of the patient.Ultimately, both the connect dilator and mechanical guidewire were removed together out of the watchman sheath.In addition, the dilator tip was reported to be found damaged/defective after it was removed, it was manually reshaped but not to an excessive degree.The guidewire was exposed to the patient when it got stuck during withdrawal.No damaged was noted on the guidewire after removal from the body or prior to insertion.Next, the physician inserted the versacross rf wire into the svc and loaded a new versacross connect dilator into the watchman sheath over it.The procedure was completed successfully.No patient complications reported.Product is not expected to return as it was disposed of at the facility.It was also mentioned that the dilator tip was damaged.
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.

• 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 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: 18441449
• Report Number: 2124215-2023-72359
• Device Sequence Number: 7847135
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/03/2024

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: 08/03/2025
• Device Lot Number: VMFE290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female