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

Model Number	VXAK0107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pericardial effusion after the transseptal puncture (tsp).During a concomitant left atrial appendage procedure (laac) and radiofrequency (rf) ablation procedure a versacross connect laac access solution rf wire was used.Femoral access was gained; a non-boston scientific intracardiac echocardiography (ice) catheter was inserted into the right atrium (ra), a non-boston scientific coronary sinus (cs) catheter was inserted and positioned at the cs, and a non-boston scientific sheath was inserted over a non-boston scientific.032-inch j-tip guidewire and positioned at the septum.The j-wire was exchanged for the verascross connect rf wire and the tsp was performed.The non-boston scientific sheath dilator was used with the rf wire.The physician was not satisfied with the position of the tsp, so the rf wire was pulled back into the ra, and the tsp procedure was repeated in an inferior/posterior location.Difficulty was encountered advancing the sheath across the septum, and the physician had to push a little harder to get it across.It was stated that the rf wire may have also advanced across the septum when the sheath did.A routine imaging sweep of the cardiac structures was then performed, and a large effusion was observed at the apex around the right ventricle (rv) and left ventricle (lv).The patient's carbon dioxide (co2) readings were also beginning to drop at this time.The sheath was pulled back to the ra and protamine was administered.The procedure was cancelled and pericardiocentesis was performed.The pericardial space was accessed using fluoroscopy and a drainage catheter was inserted.1200cc of bright red blood was removed from the epicardial space.The physician waited and observed the epicardial space to make sure blood was no longer accumulating, then the drain was removed and the patient was extubated.A blood draw for a complete blood count (cbc) was done and sent to the lab.The patient regained consciousness prior to being moved to the intensive care unit (icu) for observation.Echocardiography was performed the next day and was negative for effusion.The patient began taking apixaban again after no effusion was observed on imaging.The patient was monitored in the icu for one more night before being discharged.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.When any further relevant information is obtained, a supplemental medwatch will be filed.

• Brand Name: VersaCross Connect LAAC Access Solution
• 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: 50691337
• Report Number: 2124215-2026-48120
• Device Sequence Number: 21246245
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/09/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0039597487
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 06/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 235 LB