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); Pericardial Effusion (3271)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the radiofrequency (rf) wire had difficulty to crossing the septum and advancing into the left atrium (la) and the patient experienced cardiac tamponade, pericardial effusion, and hypotension.During an ablation procedure to treat paroxysmal atrial fibrillation a versacross connect access solution for faradrive rf wire was used.A cavotricuspid isthmus ablation was performed with a non-boston scientific rf catheter prior to attempting the transseptal puncture (tsp).The versacross connect for faradrive system was positioned in optimal tsp position using fluoroscopy and intracardiac echocardiography (ice).The rf wire crossed the septum, but the tip got caught either on the septum or the la free wall during the one second rf cautery period.There was some difficulty advancing the wire and the physician stated this did not feel normal.The faradrive sheath was advanced into the la, and the versacross connect rf wire and dilator were removed from the patient.Preparations were made to insert a non-boston scientific mapping catheter into the sheath, but it was found that the sheath had lost transseptal access.Another tsp was to be attempted with the rf wire and dilator when it was found that the patient's blood pressure was 60/40 mmhg.The ice catheter was moved into position to observe the rv and an effusion was observed.Pericardiocentesis was performed, draining a minimal amount of blood.The procedure was cancelled due to the adverse event.The patient fully recovered and was discharged home.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.When any further relevant information is obtained, a supplemental medwatch will be filed.

• 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: 50852630
• Report Number: 2124215-2026-50382
• Device Sequence Number: 21206679
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0039766875
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 06/01/2026
• 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
• Patient Age: 71 YR
• Patient Sex: Female