MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported a pericardial effusion (pe) and cardiac tamponed occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect for laac kit was selected for use.The physician used the watchman double curve sheath with the versacross connect dilator over the versacross rf wire for transseptal puncture (tsp).The tsp was performed successfully in an inferior/anterior location on the septum.The versacross rf wire was placed across into the left atrial appendage (laa).The physician was having difficulty to cross the septum with the watchman sheath under intracardiac echocardiography (ice) guidance and requested for transesophageal echocardiogram (tee) guidance.The physician was then able to cross the sheath and at this time, it was noted that the patient blood pressure dropped and medications was given to the patient.The tee operator assessed for effusion which was noticed post sheath crossing.The physician decided to abort the procedure and removed the sheath and versacross rf wire.An approximate of 350ml blood removed and pericardial drain was placed.The patient was stable at end of procedure and was taken to intensive care for observation and discharged on (b)(6) 2024.The device is not expected to be returned for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin no antiplatelet drugs at the time, a cardiac tamponade noted.There was no difficulty with tsp however, the physician feels that he pushed through the appendage when trying to advance the sheath across the septum.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20821366
• Report Number: 2124215-2024-75828
• Device Sequence Number: 8716996
• Product Code: DXF
• UDI-Device Identifier: 00685447018339
• UDI-Public: 00685447018339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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
• Report Date (Section B): 12/02/2024

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 Model Number: VXAK0001
• Device Catalogue Number: VXAK0001
• Device Lot Number: 0033983307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White