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

Model Number	VXSK0122
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a pericardial effusion growing to a cardiac tamponade following a cardiac perforation requiring a pericardiocentesis, exploratory open-heart surgery, medication, and extended hospitalization.The ablation procedure was unable to be completed due to this adverse event.A versacross access solutions kit was selected for use for the transseptal access portion of a farapulse procedure to treat atrial fibrillation.Femoral access was achieved and a non-boston scientific (bsc) sheath and the radio frequency (rf) pigtail wire from a fixed curve versacross kit were advanced into the superior vena cava (svc) with the use of intracardiac echocardiography (ice).At this time, ice showed a trace amount of effusion in the pericardial space.The non-bsc sheath was dropped down onto the atrial septum for transeptal access.Access was gained on the mid septum with veins in view.The rf pigtail wire was advanced into the left superior pulmonary vein (lspv) and the non-bsc sheath was advanced into the left atrium.The non-bsc dilator and rf pigtail wire were removed.The non-bsc sheath was aspirated and flush.A merit guidewire and non-bsc mapping catheter were inserted into the non-bsc sheath and advanced into the left atrium.A pre-ablation map of the left atrium was made.The pericardial effusion seen on precheck had grown slightly bigger than previously observed.The decision was made to continue with ablation procedure and monitor it.The non-bsc mapping catheter was removed and the non-bsc sheath was aspirated and flushed again.A farawave catheter was inserted into the non-bsc sheath and advanced into the left atrium over the merit guidewire, which was parked in the lspv.Therapy was delivered to the lspv and left carina.The farawave catheter was moved to the left inferior pulmonary vein (lipv) and the effusion was assessed again.The effusion had increased significantly in size.Assistance was called for from cath lab and a second cardiologist was called to perform a pericardiocentesis.The lipv was isolated during this time and the farawave catheter and non-bsc sheath were pulled back to the right atrium.The second physician arrived by this point and pericardial access was achieved.Protamine was given to reverse heparin.After roughly 45 minutes, bleeding into pericardial space slowed down.Praxbind was given at to reverse pradaxa.Effusion growth had greatly slowed but still was happening despite intervention.It was decided at this time the patient would go for exploratory open-heart surgery to look for any active bleeding.During this additional surgery, a blood clot was cleared out of the epicardial space.No surgical repair was performed as the bleeding had stopped by that time.No perforation could be identified.The patient was transferred to the intensive care unit (icu).The patient has fully recovered and was discharged on (b)(6)2026.

• Brand Name: VersaCross Access Solution
• Common Device Name: Catheter, Septostomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50000315
• Report Number: 2124215-2026-39723
• Device Sequence Number: 21486326
• Product Code: DXF
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)290215(10)39209244
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 09/10/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0039209244
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 143 LB