MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect Access Solution for FARADRIVE; dilator, vessel, for percutaneous catheterization

Model Number	VXAK0041
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); 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 cardiac tamponade and hypotension.The procedure was cancelled.A faradrive sheath and a versacross connect access solution for faradrive were selected to perform a pulse field ablation for the isolation of pulmonary veins to treat atrial fibrilation.A cardiac tamponade occurred during transeptal access.The physician had access with the patient heparinized to a target of 350 act.A non-boston scientific catheter was sitting in the right ventricle during transeptal.Ice was introduced into the right atrium first and base line cardiac characteristics were assessed with no fluid apparent at baseline in the pericardial space.Access was obtained with a 10f sheath which was then upsized to the faradrive over the versacross wire.The pigtail of the versacross wire was sitting up in the superior vena cava (svc).The faradrive drive sheath was advanced up to the superior vena cava (svc).The physician proceeded to perform a drop down onto the fossa ovalis under flouroscopic and ice guidance.Tenting on the fossa ovalis was confirmed and the physician crossed into the left atrium (la) with the versacross wire confirmed under ice.The patient had a lipomatus septum making it difficult to advance the sheath and dilator across.The physician pulled the wire back into the right atrium and placed the pigtail back into the svc to reattempt the drop down.There were 3 more drop downs attempted without rf energy delivered.Blood pressure began to drop, and the pericardium was checked under ice.A large effusion was observed.Protamine was given and a pericardiocentesis was performed with 700 ml of blood was removed from the pericardial space.The patient was admitted in stable condition and is expected to fully recover.
Additional Manufacturer Narrative
Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress.If additional information is obtained, supplemental report will be submitted.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• Common Device Name: dilator, vessel, for percutaneous catheterization
• 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: 25796582
• Report Number: 2124215-2026-36956
• Device Sequence Number: 5852155
• Product Code: DRE
• UDI-Device Identifier: 00685447019046
• Combination Product (Y/N): N
• Initial Reporter State: ON
• Initial Reporter Country: CA
• PMA/510(K) Number: K233647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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: 0038000723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 07/09/2026; 08/30/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/06/2026; 09/15/2026
• Date Device Manufactured: 05/22/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown