MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS LARGE ACCESS SOLUTION; PERCUTANEOUS ATRIAL CATHETER KIT

Model Number	VLAK0109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a farawatch procedure, a versacross connect access solution for faradrive and versacross large access solution was selected for use.A small pericardial effusion was noted at baseline on ice.Ablation had just begun, and while confirming catheter contact on ice in the left superior pulmonary vein, a larger and growing effusion was observed.No resistance was felt while maneuvering any catheters.Despite the enlarging effusion, the physician elected to continue the procedure to complete both the ablation and the watchman implant.A pericardiocentesis was performed at the end of the case, and 900 ml of blood was removed.The location of a perforation was not confirmed, and no imaging identifying a perforation site was available.The patient was admitted to the hospital following the complication.The device is not available for return as it was retained by the account.
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.
Additional Manufacturer Narrative
Investigation summary: based on the available information, although no product has been returned due to disposal, we have determined that the cardiac tamponade and pericardial effusion is a known inherent risk with use of this product.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated the device is unavailable for return; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use confirmed that cardiac tamponade and pericardial effusion is addressed as a potential procedural complication when using versacross large access solution.Additionally, based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Risk review: a risk review performed for the versacross large access solution device confirmed that the event of cardiac tamponade and pericardial effusion is a known event defined in the product's 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 large access solution device is acceptable.Investigation conclusion: based on the information provided, the reported event of cardiac tamponade and pericardial effusion is a known inherent risk of versacross large access solution.There were no indications that the device was used outside the bounds of labeled/indicated use or evidence of a product performance related issue.
Event or Problem Description
During a farawatch procedure, a versacross connect access solution for faradrive and versacross large access solution was selected for use.A small pericardial effusion was noted at baseline on ice.Ablation had just begun, and while confirming catheter contact on ice in the left superior pulmonary vein, a larger and growing effusion was observed.No resistance was felt while maneuvering any catheters.Despite the enlarging effusion, the physician elected to continue the procedure to complete both the ablation and the watchman implant.A pericardiocentesis was performed at the end of the case, and 900 ml of blood was removed.The location of a perforation was not confirmed, and no imaging identifying a perforation site was available.The patient was admitted to the hospital following the complication.The device is not available for return as it was retained by the account.

• Brand Name: VERSACROSS LARGE 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; 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: 24650601
• Report Number: 2124215-2026-15541
• Device Sequence Number: 9786434
• Product Code: OFK
• UDI-Device Identifier: 00685447019565
• UDI-Public: (01)00685447019565(17)280116(10)35979208
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/22/2026

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: VLAK0109
• Device Catalogue Number: VLAK0109
• Device Lot Number: 0035979208
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 01/16/2025
• 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 Sex: Unknown