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

Model Number	VXAK0041
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure for the treatment of paroxysmal atrial fibrillation, a versacross connect access solution for faradrive was selected for use.Prior to the procedure, an echocardiogram was performed and showed no evidence of thrombus or pericardial effusion.During transseptal access, the first puncture attempt was unsuccessful because the wire did not advance appropriately.The physician repositioned the system and a second attempt was successful.The transseptal puncture was performed under echocardiographic guidance.Approximately 30 minutes after ablation had commenced, during ablation of the third right inferior pulmonary vein (ripv), a significant drop in the patient's blood pressure was observed.Echocardiographic evaluation revealed a pericardial fluid collection along the anterior aspect of the right ventricle.At the time the event was identified, the catheter was reported to be located within the inferior vena cava.The procedure was completed and pericardial drainage was performed to address the accumulating blood.Due to the severity of the event, a cardiac surgeon was consulted and surgical intervention was undertaken.Following surgical opening of the chest, a perforation was identified in the anterior portion of the right atrium/right ventricular region.Approximately 1.5 liters of blood were drained from the pericardial space.The patient required a blood transfusion and surgical repair with internal suturing of the perforation was performed.The patient required hospitalization and/or prolongation of hospitalization due to the event.It was further reported that the versacross access solution remained inside the patient's body when the patient complication began.The rf wire was exposed during the transseptal procedure.No issues were reported with the ablation procedure, no thrombus was observed, and no device malfunction was identified.It was confirmed that blood leakage from the right atrium into the pericardial space occurred, resulting in cardiac tamponade.However, it could not be confirmed whether the tamponade was caused by the wire or the dilator.In the physician's opinion, the access solution (transseptal products) contributed to the patient complication.
Additional Manufacturer Narrative
B5: describe event or problem - updated.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• 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: 50779973
• Report Number: 2124215-2026-49262
• Device Sequence Number: 21521257
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0039474657
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 05/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARAWAVE NAV Catheter (BSC)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male