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

Model Number	VXSK0122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.During a pulmonary vein isolation procedure to treat atrial fibrillation, an versacross access solution was selected for use.After completing the transseptal puncture, the physician advanced the versacross wire into the left atrium, resulting in a perforation of the left atrial appendage.The patient's blood pressure and pulse dropped significantly, and a pericardial effusion was confirmed using ice and fluoroscopy.A pericardiocentesis was performed, and the patient was stabilized.The patient was admitted to the intensive unit of care (icu).The device is not expected to be returned for investigation, as it was disposed of at the facility.
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.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.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a pericardial effusion occurred.During a pulmonary vein isolation procedure to treat atrial fibrillation, an versacross access solution was selected for use.After completing the transseptal puncture, the physician advanced the versacross wire into the left atrium, resulting in a perforation of the left atrial appendage.The patient's blood pressure and pulse dropped significantly, and a pericardial effusion was confirmed using ice and fluoroscopy.A pericardiocentesis was performed, and the patient was stabilized.The patient was admitted to the intensive unit of care (icu).The device is not expected to be returned for investigation, as it was disposed of at the facility.It was further reported that the versacross wire was in the patient body during the time of complication.The wire did not malfunction or cause the issue, this was physician/ usage dependent.In the physician opinion, it is not believed that the transeptal product contributed to the complication.Prior to the perforation the patient was hemodynamically stable.The patient had a very floppy/ loose septum which caused the physician to press out further into the left atrium when going transeptal.The patient was hospitalized beyond standard care of time but was in a stable state very soon after complication.Patient has been discharged.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Investigation summary: based on the available information, although the product was disposed of and could not be returned, we have determined that the pericardial effusion, hypotension, bradycardia and cardiac perforation are known inherent risk of use of this device.Device history record review: a ship history review (37905720, 37859248, 37859248) 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: the versacross access solution ifu includes perforation and/or tamponade, arrhythmias and additional surgical procedure as an adverse event that may occur during the procedure.Furthermore, the ifu provides the warning: "careful manipulation of the versacross rf wire must be performed to avoid vessel trauma.If resistance is encountered, do not use excessive force to advance or withdraw the versacross rf wire or ancillary sheath and dilator assembly." additional review is not required.Relevant instructions are therefore captured.Risk review: a risk review performed for the versacross access solution device confirmed that the events of pericardial effusion, hypotension, bradycardia and cardiac perforation are known events 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 access solution device is acceptable.Investigation conclusion: based on the information provided, the reported events of pericardial effusion, hypotension, bradycardia and cardiac perforation are known inherent risks of the versacross access solution device.Pericardial effusion, hypotension, bradycardia and cardiac perforation is an expected procedural complication addressed within the ifu for the versacross access solution.There were no allegations of a quality or manufacturing deficiency leading to the adverse event as reported to bsc, and the device has not been returned for analysis at this time.
Event or Problem Description
It was reported that a pericardial effusion occurred.During a pulmonary vein isolation procedure to treat atrial fibrillation, an versacross access solution was selected for use.After completing the transseptal puncture, the physician advanced the versacross wire into the left atrium, resulting in a perforation of the left atrial appendage.The patient's blood pressure and pulse dropped significantly, and a pericardial effusion was confirmed using ice and fluoroscopy.A pericardiocentesis was performed, and the patient was stabilized.The patient was admitted to the intensive unit of care (icu).The device is not expected to be returned for investigation, as it was disposed of at the facility.It was further reported that the versacross wire was in the patient body during the time of complication.The wire did not malfunction or cause the issue, this was physician/ usage dependent.In the physician opinion, it is not believed that the transeptal product contributed to the complication.Prior to the perforation the patient was hemodynamically stable.The patient had a very floppy/ loose septum which caused the physician to press out further into the left atrium when going transeptal.The patient was hospitalized beyond standard care of time but was in a stable state very soon after complication.Patient has been discharged.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24241550
• Report Number: 2124215-2026-05907
• Device Sequence Number: 9184111
• Product Code: DXF
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824
• 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,Followup,Followup
• Report Date (Section B): 03/24/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/02/2026; 02/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/23/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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