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	Blurred Vision (2137); Numbness (2415)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced vision blurred and numbness in the left arm.During a pulse field ablation procedure (pfa) to treat atrial fibrillation a farawave cathether and a versacross connect access solution for faradrive were selected for use.No issues with the transseptal puncture was reported.Right inferior pulmonary vein (ripv) was extremely small, while in basket, 301 errors were received, catheter was repositioned and still received errors and ultimately the catheter formed a cobra shape.It was removed the catheter and manually separated the splines, went back into the left atrium (la) and tried to reattempt basket in the ripv, catheter went cobra again.There was difficulty delivering the basket into the ripv.Bubbles appeared while delivering in basket configuration due to something that typically occurs which is caused by an inadequate tissue contact because the basket is undersized.If the electrodes are too close, the system has a built-in safety mechanism that automatically discontinues energy delivery.Physician indicated that there may have been excessive therapy delivery in the ripv region.Physician believes that 301 errors and additional application outside of workflow contributed to the issue.Catheter was replaced because it assumed a cobra shape configuration and after replacing it was segmented the ripv with flower.Procedure was completed.It was notified that patient experienced symptoms concerning for a possible transient ischemic attack (tia).The patient underwent imaging to evaluate for a stroke, which did not demonstrate evidence of a stroke.It was stated that the patient is now doing well; however, the symptoms occurred on two separated occasions during recovery and included left arm numbness and blurred vision.No further information was provided.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 50228399
• Report Number: 2124215-2026-43333
• Device Sequence Number: 10256613
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)290504(10)39443685
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/14/2026

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: 0039443685
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown