MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Dynamic XT; catheter, electrode recording, or probe, electrode recording

Model Number	M0042011010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Pericarditis (4448)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion and cardiac tamponade occurred.Dynamic xt electrode catheter was selected for single shot ablation procedure.It was mentioned that the preparation of the materials (faradrive sheath and versacross connect wire with dilator) for the transseptal puncture, as well as the advancement of the catheter into the right atrium, proceeded smoothly without any issues.The transseptal puncture was performed under transesophageal echocardiography (tee) guidance.The physician positioned the transseptal puncture device.Initially, the tenting appeared slightly anterior; however, it was not close to the aorta and was located in the region of the patent foramen ovale (pfo).The physician performing the tee requested a slight adjustment to optimize the puncture site.Repositioning the device was achieved without difficulty.Rf was delivered using the transseptal puncture generator.The wire crossed the interatrial septum in an inferior position, well away from the aorta.After confirming the wire position by both tee and fluoroscopic imaging, it was visualized in the left superior pulmonary vein.The physician then advanced the faradrive sheath into the left atrium.According to the hospital standard protocol, tee is performed immediately after transseptal puncture to assess for the presence of a pericardial effusion.During this assessment, a large pericardial effusion was identified.The puncture sequence was reviewed it was confirmed that the effusion had already been present prior to the transseptal puncture.Emergency measures, including intubation and pericardiocentesis, were initiated immediately.During the course of treatment, the patient required resuscitation.Once the patient's condition had stabilized, the treating physicians decided to transfer the patient by ambulance to a cardiac surgery center.The patient was transported with the faradrive sheath remaining in place and a pericardial drainage catheter inserted, allowing continuous aspiration of blood accumulating within the pericardial space during transport.It was further confirmed that the patient is still in hospital.Dynamic xt catheter, the faradrive sheath and the versacross connect system was used.No intervention needed.
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.

• Brand Name: Dynamic XT
• Common Device Name: catheter, electrode recording, or probe, electrode recording
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50133533
• Report Number: 2124215-2026-41784
• Device Sequence Number: 5637471
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: M0042011010
• Device Catalogue Number: M0042011010
• Device Lot Number: 0038300828
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 01/10/2026
• 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; Life Threatening; Hospitalization
• Patient Sex: Unknown