MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Introducer, Catheter

Model Number	VXSK0121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during atrial fibrillation procedure a farawave and versacross access solution were selected for use.When trying to perform basket in the ripv, the spline became inverted.It was tried manually fixing the spline, but after going back into the left atrium, the catheter inverted again.Manually fixing the splines but did not work.Ablation was finished and it was noticed a pericardial effusion around 4 hours after the procedure.The catheter had some resistance with the wire when trying to take the catheter out of the body and the splines were inverted at that point.Patient was admitted to the hospital and a pericardiocentesis was performed.Patient has been discharged.
Additional Manufacturer Narrative
We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.

• Brand Name: VersaCross Access Solution
• Common Device Name: Introducer, Catheter
• 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: 50240115
• Report Number: 2124215-2026-43491
• Device Sequence Number: 13350511
• Product Code: OFK
• UDI-Device Identifier: 00685447019817
• UDI-Public: (01)00685447019817
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 08/13/2026

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: VXSK0121
• Device Catalogue Number: VXSK0121
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARAWAVE M004PF41M411, Lot Number: 38950566
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown