MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0041
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
During a pulse field ablation (pfa) a faradrive steerable sheath clear and versacross connect access solution for faradrive was selected for use.Pfa af ablation.Right femoral access was obtained using a short 6fr sheath and a 7fr sheath under ultrasound guidance, and heparin was administered.The versacross connect (vcc) pigtail was advanced, followed by exchanging the vcc with dilator over the 6fr sheath.There was difficulty advancing the sheath over the wire, leading to the use of peripheral dilators.The team then switched from the vcc dilator to the fd dilator, which provided some improvement, but advancement was still unsuccessful.Significant bleeding developed at the puncture site, and the first act measured 406 seconds.It was determined that a small arteriole had been punctured and possibly wired, resulting in a likely small vessel tear that was managed with manual pressure.An attempt was made to obtain left femoral vein access, but ultrasound showed the femoral artery positioned above the vein, preventing access.The procedure was aborted, heparin was reversed with protamine, and anesthesia was discontinued with the patient extubated in the ep lab.The patient was admitted for overnight monitoring and hemostasis.The patient was present during the event and experienced bleeding, though the physician did not believe the device or procedure caused or contributed to the complication.A compression device was applied to the right femoral arterial puncture site.The patient required hospital admission beyond standard care and had not yet been discharged, but was expected to fully recover.The procedure was unsuccessful due to the inability to advance the sheath to the heart from either femoral vein.At the time the procedure was cancelled, the patient was under general anesthesia.
Event or Problem Description
During a pulse field ablation (pfa) a faradrive steerable sheath clear and versacross connect access solution for faradrive was selected for use.Pfa af ablation.Right femoral access was obtained using a short 6fr sheath and a 7fr sheath under ultrasound guidance, and heparin was administered.The versacross connect (vcc) pigtail was advanced, followed by exchanging the vcc with dilator over the 6fr sheath.There was difficulty advancing the sheath over the wire, leading to the use of peripheral dilators.The team then switched from the vcc dilator to the fd dilator, which provided some improvement, but advancement was still unsuccessful.Significant bleeding developed at the puncture site, and the first act measured 406 seconds.It was determined that a small arteriole had been punctured and possibly wired, resulting in a likely small vessel tear that was managed with manual pressure.An attempt was made to obtain left femoral vein access, but ultrasound showed the femoral artery positioned above the vein, preventing access.The procedure was aborted, heparin was reversed with protamine, and anesthesia was discontinued with the patient extubated in the ep lab.The patient was admitted for overnight monitoring and hemostasis.The patient was present during the event and experienced bleeding, though the physician did not believe the device or procedure caused or contributed to the complication.A compression device was applied to the right femoral arterial puncture site.The patient required hospital admission beyond standard care and had not yet been discharged, but was expected to fully recover.The procedure was unsuccessful due to the inability to advance the sheath to the heart from either femoral vein.At the time the procedure was cancelled, the patient was under general anesthesia.
Additional Manufacturer Narrative
Correction to the initial mdr in block h6.The reported allegations are not confirmed as the device was not returned and no media has been provided.Dhr/service history review: the dhr for the dilator, 37994334, 37999128, 38045943, 38135682, and 38149384, were reviewed.There was no indication that a deviation or nonconformance associated with the manufacturing process contributed to this event.Additional review is not required.Risk review: a risk review performed for the versacross connect access solution for faradrive device confirmed that the event of vessel trauma, hemorrhage is a known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the versacross connect access solution for faradrive device is acceptable.Labeling review: the instructions for use were reviewed, and it did not reveal any evidence of device off label use or failure to follow instructions.The ifu mentions: "vessel trauma and hemorrhage".There is no evidence that any updates to the document are required at this time.The information within the event description suggests that the clinical event is anticipated in nature as per the ifu as reported to bsc.At this point, it can be concluded that "known inherent risks of device" use most probably contributed to the events adverse event.Leading potential causes include patient anatomy and physician technique.There is no evidence manufacturing caused or contributed.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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 ; 6514400979
• MDR Report Key: 25211205
• Report Number: 2124215-2026-26814
• Device Sequence Number: 13380242
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)281118(10)38214149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: 0038214149
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 11/19/2025
• 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 Sex: Unknown