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

Model Number	VXSK0131
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion, hypotension and tachycardia occurred.A pulmonary vein isolation (pvi) procedure utilizing pulse field ablation (pfa) was planned for the treatment of paroxysmal atrial fibrillation.A versacross access solution was selected for transseptal access.During the procedure, the physician performed transseptal puncture using the versacross rf wire through a non-boston scientific (non-bsc) sheath.Rf energy was delivered via a baylis generator, and the non-bsc sheath was advanced over the wire.No resistance was encountered while advancing or maneuvering any catheters or devices, and no issue was noted during the transseptal access.Following successful transseptal access, the versacross rf wire was removed.During left atrial mapping with a non-bsc mapping catheter and prior to delivery of any ablation lesions, the patient became hemodynamically unstable, with a decrease in blood pressure and an increase in heart rate.Evaluation identified a pericardial effusion.The physician withdrew the equipment into the right atrium and performed pericardiocentesis with placement of a pigtail drain.The effusion was treated before progression to cardiac tamponade.No specific perforation site was identified.No ablation lesions were delivered, and the procedure was discontinued due to the patient's medical condition.The physician reported that the versacross access solution functioned as intended and exhibited no malfunction.The physician believed the complication was associated with the non-bsc mapping catheter and that the versacross access solution did not contribute to the event.The patient was admitted for observation and was discharged the following day.
Event or Problem Description
It was reported that pericardial effusion, hypotension and tachycardia occurred.A pulmonary vein isolation (pvi) procedure utilizing pulse field ablation (pfa) was planned for the treatment of paroxysmal atrial fibrillation.A versacross access solution was selected for transseptal access.During the procedure, the physician performed transseptal puncture using the versacross rf wire through a non-boston scientific (non-bsc) sheath.Rf energy was delivered via a baylis generator, and the non-bsc sheath was advanced over the wire.No resistance was encountered while advancing or maneuvering any catheters or devices, and no issue was noted during the transseptal access.Following successful transseptal access, the versacross rf wire was removed.During left atrial mapping with a non-bsc mapping catheter and prior to delivery of any ablation lesions, the patient became hemodynamically unstable, with a decrease in blood pressure and an increase in heart rate.Evaluation identified a pericardial effusion.The physician withdrew the equipment into the right atrium and performed pericardiocentesis with placement of a pigtail drain.The effusion was treated before progression to cardiac tamponade.No specific perforation site was identified.No ablation lesions were delivered, and the procedure was discontinued due to the patient's medical condition.The physician reported that the versacross access solution functioned as intended and exhibited no malfunction.The physician believed the complication was associated with the non-bsc mapping catheter and that the versacross access solution did not contribute to the event.The patient was admitted for observation and was discharged the following day.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of a pericardial effusion, hypotension, tachycardia and use of device issue - misuse.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review performed for the versacross device confirmed that the event of pericardial effusion, hypotension, tachycardia and use of device issue - misuse are known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: based on the information provided, the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Investigation conclusion: boston scientific has assigned an investigation conclusion code of failure to follow instructions, known inherent risk of device and supporting evidence that came to this conclusion.Per the label review, the clinical events are anticipated in nature through residual risk communicated in the ifu.There are several factors that may have contributed to the adverse event(s), such as excessive force during rfw advancement, use of incompatible device, underlying patient condition, insufficient imaging, tortuous or challenging patient anatomy, or physician/scrub tech technique.It was noted that the rfw was used with an incompatible device for tsp.Boston scientifics investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• Brand Name: VersaCross Access Solution
• Common Device Name: Catheter, Septostomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 ; CA 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: 50175687
• Report Number: 2124215-2026-42412
• Device Sequence Number: 12832565
• Product Code: DXF
• UDI-Device Identifier: 00685447019862
• UDI-Public: (01)00685447019862(17)290325(10)39409628
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/17/2026

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: VXSK0131
• Device Catalogue Number: VXSK0131
• Device Lot Number: 0039409628
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Agilis 13F Sheath (Abbott); Agilis 13F Sheath (Abbott).; HD Grid Mapping Catheter (Abbott); HD Grid Mapping Catheter (Abbott).; RF Generator (Baylis); RF Generator (Baylis).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female