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

Lot Number VMFC290523

Device Problems Difficult to Remove (1528); Defective Device (2588); Component or Accessory Incompatibility (2897)

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

Event Date 07/26/2023

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 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 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.

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
• 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: 17565394
• MDR Text Key: 321534061
• Report Number: 2124215-2023-43649
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• 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: 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
• Device Operator: Health Professional
• Device Lot Number: VMFC290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR