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

Model Number	VXAK0107
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.It was not available because the healthcare facility is unavailable to provide the lot number.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 pericardial effusion, cardiac perforation occurred.During a left atrial appendage (laa) closure procedure using a watchman flx pro in a patient with atrial fibrillation, versacross connect pigtail rf wire was used with a non-boston scientific sheath and catheter to perform transseptal puncture.The initial attempt to advance the non-boston scientific sheath across the septum was unsuccessful.The versacross pigtail rf wire was withdrawn into the right atrium, and a second transseptal puncture was performed inferior to the original puncture site.Following successful transseptal puncture using the versacross pigtail rf wire, the non-boston scientific sheath, pigtail catheter were advanced.Contrast injection demonstrated contrast within the pericardial space, resulting pericardial effusion.Transesophageal echocardiography (tee) confirmed compression of the heart due to fluid accumulation within the pericardial space.A pericardiocentesis was performed, and bright red blood was aspirated and transfused back to the patient.An atrial septal defect (asd) closure device was implanted.The reported perforation site was the posterior wall; however, a specific perforation point was not visualized.The patient was receiving plavix therapy.The planned laa closure device was not deployed, and no surgical intervention was required.The patient was managed with pericardiocentesis and asd closure device placement.
Event or Problem Description
It was reported that pericardial effusion, cardiac perforation occurred.During a left atrial appendage (laa) closure procedure using a watchman flx pro in a patient with atrial fibrillation, versacross connect pigtail rf wire was used with a non-boston scientific sheath and catheter to perform transseptal puncture.The initial attempt to advance the non-boston scientific sheath across the septum was unsuccessful.The versacross pigtail rf wire was withdrawn into the right atrium, and a second transseptal puncture was performed inferior to the original puncture site.Following successful transseptal puncture using the versacross pigtail rf wire, the non-boston scientific sheath, pigtail catheter were advanced.Contrast injection demonstrated contrast within the pericardial space, resulting pericardial effusion.Transesophageal echocardiography (tee) confirmed compression of the heart due to fluid accumulation within the pericardial space.A pericardiocentesis was performed, and bright red blood was aspirated and transfused back to the patient.An atrial septal defect (asd) closure device was implanted.The reported perforation site was the posterior wall; however, a specific perforation point was not visualized.The patient was receiving plavix therapy.The planned laa closure device was not deployed, and no surgical intervention was required.The patient was managed with pericardiocentesis and asd closure device placement.It was further reported that the patient remained hospitalized overnight for observation and was discharged the following day.The patient was reported to be recovering as expected.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.It was not available because the healthcare facility is unavailable to provide the lot number.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of e0619 pericardial effusion, e0604 cardiac perforation, and a2304 off-label use.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the lot number was not provided; therefore, a ship history of previous lots sent to the customer were reviewed.The manufacturing batch record review confirmed that the devices met all material, assembly, and performance specifications.Labeling review: based on the information provided, there was evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review: a risk review performed for the versacross connect access solution device confirmed that the events of e0619 pericardial effusion, e0604 cardiac perforation, and a2304 off-label use are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of failure to follow instructions and supporting evidence that came to this conclusion.Boston scientifics investigation findings where tsp was performed using a different non-boston scientific sheath which is considered off label use as per the ifu.The adverse events are known inherent risk of device; therefore, known inherent risk of device added.The device met all requirements prior to being approved for final distribution/sale and there was evidence to suggest that the instructions for use (ifu) was not followed.Additional information to section b5.

• Brand Name: VersaCross Connect LAAC 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 ; +1(651)440-0979
• MDR Report Key: 25874102
• Report Number: 2124215-2026-38735
• Device Sequence Number: 18157017
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/25/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male