MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Percutaneous atrial catheter kit

Model Number	VXSK0134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was mention that pericardial effusion was noted and the procedure was cancelled.It was mentioned that versacross access solution was selected for atrial fibrillation (a fib).It was mentioned that during the procedure once the patient was sedated, rf and watchman was implanted using philips 4d ice and fluoroscopy.Ultrasound guided venous access 3 was obtained without difficulty.Intracardiac echocardiography (ice) imaging confirmed the left atrial appendage (laa) was free of clots.A baseline pericardial effusion of 0.7 cm was noted on circumferential but mostly on rv side.Half dose heparin was administered.Transeptal puncture was performed.The versacross device was easily visualized, and the transseptal puncture was inferior/posterior.Wire and sheath crossed without issue.Carto mapping indicated the patient had a very small left atrium.During ongoing ice monitoring, the previously noted effusion appeared larger.Repeat measurement showed an increase to 1.14 cm.Heparin was reversed with protamine.The patient remained hemodynamically stable throughout.A second physician was consulted for additional assessment.Both physicians agreed that pericardiocentesis was not needed as patient was very stable and the effusion did not continue to grow.As per the physician, transeptal puncture too posterior leading to growth in pericardial effusion.The decision was made to abort the procedure and to reassess the effusion with tte in several hours.The patient was transferred to pacu in stable condition.It was further reported that the patient recovered successfully.

• Brand Name: VersaCross Access Solution
• Common Device Name: Percutaneous atrial catheter kit
• 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: 25631191
• Report Number: 2124215-2026-34084
• Device Sequence Number: 21220687
• Product Code: DYB
• UDI-Device Identifier: 00685447019893
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/18/2026

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: VXSK0134
• Device Catalogue Number: VXSK0134
• Device Lot Number: 0038599080
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 01/15/2026
• 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 Age: 73 YR
• Patient Sex: Female