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

Lot Number VMFE100423

Device Problems Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that a versacross connect access solution was selected for use during a left atrium appendage closure.During preparation, it was noted that the mechanical guidewire was not coming out of the dilator (about an inch exposed from dilator), once trying to exchange the mechanical guidewire for the versacross rf wire.It was not a smooth transition among the devices.Thus, it was needed to remove the dilator and mechanical guidewire together, hence force had to be applied to remove the guidewire from the dilator, when outside the patient anatomy.The mechanical guidewire was noted kinked and unraveled, and in one piece.The procedure was continued along with a versacross rf wire and the same dilator, and it was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis.

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
• Type of Device: 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: 17670813
• MDR Text Key: 322510476
• Report Number: 2124215-2023-47280
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2023

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
• Device Operator: Health Professional
• Device Lot Number: VMFE100423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR