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

Model Number	VXAK0005
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the versacross connect access solution was selected for use.During a left atrium appendage closure, the physician went up with mechanical guidewire and it was unable to remove it after transseptal puncture, the assembly was brought to the superior vena cava, once trying to replace the mechanical guidewire by the versacross rf wire.Thus, the versacross dilator was removed along with the stuck mechanical guidewire from body completely, and was sheath was left in place.Then, the mechanical guidewire was removed from dilator tip by pulling it from the distal end, and it was noted kinked and unraveling.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
This is supplemental mdr to report investigation results (mdr aware date 26oct2023).The product has returned for analysis.Analysis of the device found that the guidewire wire returned in one piece with coil stacking and numerous kinks which could have led to the guidewire getting stuck, the mechanical guidewire was not fractured, and excessive coating loss was noted.The versacross dilator was also severely kinked at the distal tip.Thus, a supplemental report is being filed.Also, the field b5 (describe event or problem) was updated.
Event or Problem Description
It was reported that the versacross connect access solution was selected for use.During a left atrium appendage closure, the physician went up with mechanical guidewire and it was unable to remove it after transseptal puncture, the assembly was brought to the superior vena cava, once trying to replace the mechanical guidewire by the versacross rf wire.Thus, the versacross dilator was removed along with the stuck mechanical guidewire from body completely, and was sheath was left in place.Then, the mechanical guidewire was removed from dilator tip by pulling it from the distal end, and it was noted kinked and unraveling.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

• 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: 17280548
• Report Number: 2124215-2023-35452
• Device Sequence Number: 12082406
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 11/22/2023

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 Model Number: VXAK0005
• Device Lot Number: VMFB170323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Unknown