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

Lot Number	VMFA110623
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It has been reported that a versacross connect laac access solution kit has been selected for a watchman procedure to treat a case of a non-valvular atrial fibrillation (a fib).During the procedure, the physician mentioned that they guidewire got stuck in the dilator as they attempted to withdraw it.The physician was eventually able to withdraw the wire by using excessive force and the procedure was completed successfully using a different device.No patient complications reported.The product is expected to return for analysis.
Event or Problem Description
It has been reported that a versacross connect laac access solution kit has been selected for a watchman procedure to treat a case of a non-valvular atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire got stuck in the dilator as they attempted to withdraw it.The physician was eventually able to withdraw the wire by using excessive force and the procedure was completed successfully using a different device.No patient complications reported.The product is expected to return for analysis.
Additional Manufacturer Narrative
The device has been returned for analysis (mdr aware date 09jan2024).Only the mechanical guidewire (mgw) from the kit was returned for investigation.Visual inspection of the mechanical guidewire (mgw) identified that the there was a kink near the proximal end, and the distal section of the guidewire was severely damaged with multiple sections of external coil discontinuity.Note, the coil damage is likely a result of user manipulation as it was noted through complaint information that excessive force was applied.In addition, vhx imaging revealed a fracture on the core wire, which did not exhibit signs of brittle fracture nor manufacturing defect.The reported allegations are confirmed.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: 17782967
• Report Number: 2124215-2023-51101
• Device Sequence Number: 5493069
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/05/2024

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: VMFA110623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female