MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number VMFA131023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/27/2024

Event Type  Injury  

Event Description

It has been reported that a versacross connect access solution was selected for use.A perforation, pericardial effusion and pleural effusion were noted, causing the procedure to be cancelled.During a watchman left atrial appendage closure (laac) procedure, the physician mentioned that transseptal puncture was performed successfully using the versacross connect, and the versacross rf wire was visualized in the left atrium (la).Thus, the versacross dilator was removed, and a non-boston scientific pigtail catheter was inserted and advanced it into the appendage distally.They then used dye to visualize the appendage and observed that the dye had gone into the pericardium.The patient's blood pressure began to drop, heparin was reversed, and a pericardial drain was inserted.The patient has been admitted to the hospital beyond the standard of care and is expected to fully recover.Product is not expected to return as it was disposed of at the facility.The patient received a clip the next day and was discharged the following day.No issues were noted with versacross devices.They were unable to get an act measurement, but heparin was confirmed to be reversed.In the physician's opinion, the versacross devices did not malfunction during the procedure.It is believed that it was the non-boston scientific pigtail catheter that was advanced into the laa that went through the wall of the appendage.In the physician's opinion, the appendage was perforated while performing an appendage gram.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: CATHETER, SEPTOSTOMY
• 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: 18951065
• MDR Text Key: 338257906
• Report Number: 2124215-2024-16636
• Device Sequence Number: 1
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150709
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: VMFA131023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White