MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Catheter, Septostomy

Model Number	VXAK0109
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced cardiac perforation and pericardial effusion.During withdraw for a pulsed field ablation (pfa) procedure to treat atrial fibrillation a versacross connect laac access solution rf wire was selected for use.Patient has inferior vena cava (ivc) filter, which was difficult to gain access through.Also, patient has unusual anatomy with acute angles through ivc into right atrium.A small initial trace effusion was noted using intracardiac echocardiography (ice).Physician performed transseptal procedure with versacross and non-bsc sheath.No issue to visualize the wire.Wire tented a normal amount.After, pulmonary vein isolation (pvi) and pulmonary wall isolation (pwi) ablation were completed with no observable complications.No malfunctions reported for bsc versacross or farawave.A resistance to move non-bsc sheath into the right atrium from the ivc.Nonetheless, 20 minutes post ablation, making use of ice, a larger effusion was identified.Pericardiocentesis was performed, with not full drainage or fix of the effusion.The case was escalated to and managed by the cardiothoracic surgeons, finding a tear, lateral & posterior ivc tear at ra juncture.The tear was repaired.Patient required hospitalization beyond standard care.Patient was originally inpatient at this hospital and went back to inpatient status after a short stay in the cardiac icu following their ct surgery.Physician's opinion does not believe the procedure or devices as contributors to the adverse event.The patient is expected to fully recover from the event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because device had been disposed and product information was unknown.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• Brand Name: VersaCross Connect LAAC Access Solution
• Common Device Name: Catheter, Septostomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50850409
• Report Number: 2124215-2026-50368
• Device Sequence Number: 18630350
• Product Code: DXF
• UDI-Device Identifier: 00685447019503
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: VXAK0109
• Device Catalogue Number: VXAK0109
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: 87 YR
• Patient Sex: Female