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

Lot Number	VMFC290523
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
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 was reported that during a watchman procedure to treat left atrial appendage closure (laac), a versacross connect kit was selected for use.Prior to transseptal puncture, the mechanical j-wire was in superior vena cava (svc) and it frayed/ split when it was pulled into versacross connect sheath.There was resistance felt when withdrawing the wire from the introducer.Both the versacross connect and double curve sheath were removed from the body.Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that during a watchman procedure to treat left atrial appendage closure (laac), a versacross connect kit was selected for use.Prior to transseptal puncture, the mechanical j-wire was in superior vena cava (svc) and it frayed/ split when it was pulled into versacross connect sheath.There was resistance felt when withdrawing the wire from the introducer.Both the versacross connect and double curve sheath were removed from the body.Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis yet.However, based on the media provided, the reported allegations are confirmed.The photos clearly demonstrate the frayed mechanical guidewire.Also, the fields b7 (other relevant history) and e4 (init rptr also sent rep to fda) were updated.Thus, this supplemental is being filed.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.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewire.

• 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: 17565394
• Report Number: 2124215-2023-43649
• Device Sequence Number: 17813364
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/13/2024

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: VMFC290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Unknown