MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/23/2025
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.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained yet.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a perforation, pericardial effusion (pe) and cardiac tamponade occurred.During a watchman procedure, a versacross connect laac was selected for use.After obtaining access, a intracardiac echocardiography (ice) catheter was inserted in right groin.The versacross connect was inserted in the watchman trusteer sheath and physician began clearing appendage and waiting on heparin before going transeptal.The physician had issues visualizing with ice and eventually got the imaging to go transeptal and completed the case.After the procedure while evaluating for effusion a new effusion was observed which was monitored for thirty minutes.It did not grow in size, and patient went to recovery.Shortly after the patient was brought back in for pericardiocentesis after they went into tamponade.Dull venous blood during tap, 400ml removed before they left room.Once patient was stable at this point and returned for observation with a drain in place.The physician later notified that the patient had just got out of surgery, they had found a perforation in the superior vena cava (svc) that was repaired and patient is expected to recover.The patient was hospitalized after the surgery.The current status of the patient was not disclosed.The device is not expected to be returned for analysis (disposed).

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22785863
• Report Number: 2124215-2025-56150
• Device Sequence Number: 18653432
• Product Code: DRE
• UDI-Device Identifier: 00685447019480
• UDI-Public: (01)00685447019480(17)270813(10)36497264
• 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
• Report Date (Section B): 08/12/2025

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: VXAK0105
• Device Catalogue Number: VXAK0105
• Device Lot Number: 0036497264
• 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: 07/23/2025
• Initial Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White