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

Lot Number VMFA110623

Device Problems Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

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

Event Date 08/25/2023

Event Type  malfunction  

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 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 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.

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
• 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: 17782967
• MDR Text Key: 323858620
• Report Number: 2124215-2023-51101
• Device Sequence Number: 1
• Product Code: DRE
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Lot Number: VMFA110623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female