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

Model Number	VXAK0041
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure for a pulse field ablation (pfa) and a watchman left atrial appendage closure (laac) flx pro procedure to treat atrial fibrillation a versacross connect access solution for faradrive and a farawave ablation catheter were selected for use.Procedure started at 13:00, with a patient cleared for pericardial effusion at the beginning of case by the physician.Physician experienced difficulty getting the versacross into the superior vena cava (svc) due to pacer leads, wire was exchange for j-tipped (non-bsc) wire to navigate through leads, once inside svc wire was exchanged again.Upon dropping down onto the fossa to perform transeptal puncture, with no felt resistance or difficulty, it was noted the septum was thickened, which lead to an unsuccessful first attempt to cross, second attempt was successful.Then, patient had ablation performed with no symptoms and/or decompensation.Watchman sheath was inserted at 13:58, pigtail was placed into laa and angio was performed.Drawing was marked on fluoroscopy and selected 31mm, it was prepared and inserted through trusteer sheath.With the use of tee watchman was deployed and ran through pass criteria.Implant was successful and device was released with no recaptures.Procedure was completed successfully with original devices.Final pericardial effusion check revealed large pericardial effusion collecting beneath the right ventricle, pericardiocentesis was performed.Patient was admitted the patient to the step-down cardiac unit with drain in place, requiring hospitalization beyond standard of care.Patient was discharged.The patient is expected to fully recover from the event.The physician stated that reported that during the first attempt to perform transeptal puncture rf wire crossed into the pericardial space and patient developed the pericardial effusion since that point in the procedure.The device is not expected to return as it was disposed.

• 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, 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: 50112281
• Report Number: 2124215-2026-41392
• Device Sequence Number: 18827406
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)290505(10)39515372
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/03/2026

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: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0039515372
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 05/06/2026
• 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: 81 YR
• Patient Sex: Male