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

Model Number	VXSK0033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Heart Block (4444)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
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 procedure in the left atrial appendage (laa) to treat atrial fibrillation (afib), a versacross sheath and rf wire were selected for use.Post right groin venous access the sheath and the wire were advanced to the superior vena cava (svc).The physician approached the system to the septum, but it would go to the inferior vena cava (ivc).Several attempts were performed, and the patient experienced complete heart block.Medication, cardiopulmonary resuscitation (cpr) and heart pacing also helped the patient to become hemodynamically stable.Once the patient became stable a transesophageal echocardiogram (tee) revealed a large effusion and cardiac tamponade while the system was in the right atrium (ra).The procedure was cancelled and pericardiocentesis was performed; 300 ml of fluid were drained from the pericardium.The effusion became smaller and the patient was hemodynamically stable to go to intensive care unit (icu).It is expected that the patient will fully recover.
Additional Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.
Event or Problem Description
It was reported that during procedure in the left atrial appendage (laa) to treat atrial fibrillation (afib), a versacross sheath and rf wire were selected for use.Post right groin venous access the sheath and the wire were advanced to the superior vena cava (svc).The physician approached the system to the septum, but it would go to the inferior vena cava (ivc).Several attempts were performed, and the patient experienced complete heart block.Medication, cardiopulmonary resuscitation (cpr) and heart pacing also helped the patient to become hemodynamically stable.Once the patient became stable a transesophageal echocardiogram (tee) revealed a large effusion and cardiac tamponade while the system was in the right atrium (ra).The procedure was cancelled and pericardiocentesis was performed; 300 ml of fluid were drained from the pericardium.The effusion became smaller and the patient was hemodynamically stable to go to intensive care unit (icu).T it was further reported that the device used was the versacross access system.The patient anatomy was straight forward.Multiple attempts were made to go back up to the svc and back down to fossa.No difficulty with imaging/visualizing the wire.No tenting prior to rf application.It was never tented, it had difficulties dropping into the fossa, thus transseptal was not accomplished.It has never crossed or applied radio frequency.It is unknown where the pericardial effusion located.It is possible to estimate that the pericardial effusion occurred during the attempt to drop into the fossa.The versacross wire did not malfunction.The patient is fully recovered and went home 08-apr-2023.The versacross dilator and sheath were discarded.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• 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: 16872642
• Report Number: 2124215-2023-20482
• Device Sequence Number: 17512357
• Product Code: DYB
• UDI-Device Identifier: 00685447011842
• UDI-Public: 00685447011842
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Model Number: VXSK0033
• Device Lot Number: VXFJ310822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female