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

Model Number	VXAK0105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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.A separated report for the versacross connect laac is being submitted.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.
Event or Problem Description
It was reported that a cardiac perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, two of a versacross connect laac were selected for use.A trusteer access sheath was used with a j-tip versacross connect for the procedure.The transseptal stick appeared to be mid/mid location on the septum.A perforation of the left atrium posterior wall and left atrial appendage (laa) occurred following transeptal.A pressure drop was noticed and a global pericardial effusion was noted on transesophageal echocardiogram (tee).The cardiac surgeon was call and the patient was taken to surgery where they repaired two perforations and once the patient was stabilized the appendage was clipped.The patient did well following surgery and is expected to make a full recovery.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the fields describe event or problem (b5), in section b - adverse event or product problem, patient codes, impact codes, (f10 and h6), in section f - for use by uf/importer and h - device manufacturers only.Additionally, it was confirmed that the device versacross connect laac access solution - vxak0105 reported was not involved at all in this event.A separated report for this same event was also submitted under report number - 2124215-2025-80037.
Event or Problem Description
It was reported that a cardiac perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, two of a versacross connect laac were selected for use.A trusteer access sheath was used with a j-tip versacross connect for the procedure.The transseptal stick appeared to be mid/mid location on the septum.A perforation of the left atrium posterior wall and left atrial appendage (laa) occurred following transeptal.A pressure drop was noticed and a global pericardial effusion was noted on transesophageal echocardiogram (tee).The cardiac surgeon was call and the patient was taken to surgery where they repaired two perforations and once the patient was stabilized the appendage was clipped.The patient did well following surgery and is expected to make a full recovery.The device is not expected to be returned for analysis (disposed).It was further confirmed that the kit vxak0109 was used for this procedure.Imaging was difficult for this case due to heart rotation.Rf wire was suspected cause for perforation, possibly dilator also.In the physician opinion, difficult imaging led to suboptimal transseptal location.Act was therapeutic.Patient hemodynamics was controlled well once the first tap was done and was managed well during the open-heart.The patient has been discharged.The belief is that the during the rf portion of tsp the wire slid quite superior and subsequently perforated the posterior wall of the la first.Second perforation was in the laa.Finally, there was no involvement of the kit vxak0105 in this event.

• 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 ; 6514400979
• MDR Report Key: 23480421
• Report Number: 2124215-2025-80036
• Device Sequence Number: 10203027
• Product Code: DXF
• UDI-Device Identifier: 00685447019480
• UDI-Public: (01)00685447019480
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 11/25/2025

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: VXAK0105
• Device Catalogue Number: VXAK0105
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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