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

Model Number	VXAK0041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later.Versacross connect access solution for faradrive kit was selected for use and during a transesophageal echocardiogram (tte), a pericardial effusion was noted.Patient was brought back into the room to get a pericardiocentesis.Pigtail versacross was used in the procedure.The patient has been discharged.The versacross wire is not available for return as it was discarded at the end of the case.
Event or Problem Description
It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later.Versacross connect access solution for faradrive kit was selected for use and during a transesophageal echocardiogram (tte), a pericardial effusion was noted.Patient was brought back into the room to get a pericardiocentesis.Pigtail versacross was used in the procedure.The patient has been discharged.The versacross wire is not available for return as it was discarded at the end of the case.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Correction to section g2 report source.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of cardiac tamponade, pericardial effusion, and bradycardia.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review performed for the versacross connec device confirmed that the event of cardiac tamponade, pericardial effusion and bradycardia are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Investigation conclusion: boston scientific has assigned an investigation conclusion code of no problem detected and known inherent risk of device and supporting evidence that came to this conclusion.Potential causes include misinterpretation of imaging information resulting in sub-optimal puncture location, manipulation of devices during the pulse field ablation within the patient anatomy, physician/scrub tech technique and difficult patient anatomy.Boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50546349
• Report Number: 2124215-2026-45634
• Device Sequence Number: 10589115
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown