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	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient became hypotensive and had a pericardial effusion requiring drainage.During a pulmonary vein isolation (pvi) and supraventricular tachycardia (svt) ablation procedure, a dynamic xt electrode catheter was used.At the start of the case, the physician attempted an electrophysiology (ep) study; however, placement of the coronary sinus (cs) catheter was extremely difficult due to patient's anatomy.The physician alternated between a dynamic decapolar cs catheter and an abbott livewire duodecapolar catheter for approximately an hour to gain cs access, but cs access could not be achieved, and the ep study proceeded without it.After administration of isuprel, the patient experienced a drop in blood pressure.Intracardiac echocardiography (ice) confirmed a trivial pericardial effusion, which increased slightly upon re-evaluation a minute later.Continued monitoring revealed progressive enlargement of the effusion, which prompted the use of a pericardial synthesis kit to drain approximately 200 cc of blood.Protamine was administered, and the effusion subsequently stabilized.The patient remained stable throughout the intervention and was kept overnight for observation.The ablation procedure was not completed due to the pericardial effusion.The device was retained by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.
Additional Manufacturer Narrative
Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.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.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on january 13, 2026.Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.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.
Event or Problem Description
It was reported that the patient became hypotensive and had a pericardial effusion requiring drainage.During a pulmonary vein isolation (pvi) and supraventricular tachycardia (svt) ablation procedure, a dynamic xt electrode catheter was used.At the start of the case, the physician attempted an electrophysiology (ep) study; however, placement of the coronary sinus (cs) catheter was extremely difficult due to patient's anatomy.The physician alternated between a dynamic decapolar cs catheter and an abbott livewire duodecapolar catheter for approximately an hour to gain cs access, but cs access could not be achieved, and the ep study proceeded without it.After administration of isuprel, the patient experienced a drop in blood pressure.Intracardiac echocardiography (ice) confirmed a trivial pericardial effusion, which increased slightly upon re-evaluation a minute later.Continued monitoring revealed progressive enlargement of the effusion, which prompted the use of a pericardial synthesis kit to drain approximately 200 cc of blood.Protamine was administered, and the effusion subsequently stabilized.The patient remained stable throughout the intervention and was kept overnight for observation.The ablation procedure was not completed due to the pericardial effusion.The device was retained by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.Additional information received on january 13, 2026: a photo on the imaging performed was provided, confirming the presence of the effusion.The patient was subsequently discharged and had fully recovered.

• 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 ; 6514400979
• MDR Report Key: 23866200
• Report Number: 2124215-2025-92363
• Device Sequence Number: 4438001
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: (01)08714729877615
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K921872
• 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): 02/04/2026

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
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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; Other; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male