MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; CATHETER, SEPTOSTOMY

Model Number	VXAK0045
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained yet.If there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During an atrial fibrillation procedure, a versacross connect for faradrive and a faradrive steerable sheath clear were selected for use.The physician went to do transeptal as usual.The versacross wire was advanced to superior vena cava (svc) and then faradrive.The physician confirmed it was a good thin mid mid stick, anterior was too thick and proceeded to radio frequency for transeptal.It was noted right away that the wire positioning was very off and appeared to be in pericardial space or aorta.Transeptal on intracardiac echocardiography (ice) looked very good and not too posterior or anterior.The physician felt good with positioning and then advanced the sheath across using ice.The physician was unable to aspirate back any blood and at the same time anesthesia stated there was a sharp drop in blood pressure.The faradrive was pulled back into right atrium and performed pericardiocentesis.However, the physician could not get the drain in.There was no difficulties visualizing versacross wire and 1 mm tip was tenting on septum.The physician did state that patient heart was a bit rotated.Effusion was seen on posterior side on tee and ice.No fluid was drained, failed pericardiocentesis.Physician did not state any comment on why effusion occurred.Transeptal stick was likely at mid anterior.Act was therapeutic.There was no damages noted to faradrive sheath.The patient remained intubated and was transferred to intensive care unit.The device is expected to be returned for analysis.

• 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23477213
• Report Number: 2124215-2025-79742
• Device Sequence Number: 18699032
• Product Code: DXF
• UDI-Device Identifier: 00685447019060
• UDI-Public: (01)00685447019060(17)270708(10)36140237
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: VXAK0045
• Device Catalogue Number: VXAK0045
• Device Lot Number: 0036140237
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 07/08/2024
• 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; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female