MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M0042011010
Medical Device Problem Codes	Material Perforation (2205); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal portion of the catheter shaft was damaged.During a pulmonary vein isolation (pvi) procedure to treat paroxysmal atrial fibrillation, a dynamic xt electrode catheter was used.After insertion, it was noted that there was difficulty in positioning the device, and the movement of the catheter was not as smooth as usual.The catheter was then withdrawn for inspection, wherein a crack was observed on the distal portion of the catheter shaft.Another of the same device was used, and the procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported events of catheter shaft tears/rips/holes/sep dev matrl and curve difficult to move/steer were confirmed.Visual inspection of the returned dynamic xt electrode catheter found that the shaft was cut approximately 15cm from the tip.Functional testing revealed that the catheter functional mechanism was not working properly.Media inspection on the photo of the device provided confirmed that the distal portion of the catheter shaft was damaged.The investigation concluded that factors such as handling of the device, the technique used by the physician, and the normal procedural difficulties encountered during the procedure may have affected the device performance and its integrity.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Risk review: a review of the dynamic xt electrode catheter risk documentation was completed and confirmed that the events of catheter shaft tears/rips/holes/sep dev matrl and curve difficult to move/steer were defined in the risk documentation.This event type has 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 unintended use error caused or contributed to event, as the incident occurred during the procedure and was not influenced by the device itself.
Event or Problem Description
It was reported that the distal portion of the catheter shaft was damaged.During a pulmonary vein isolation (pvi) procedure to treat paroxysmal atrial fibrillation, a dynamic xt electrode catheter was used.After insertion, it was noted that there was difficulty in positioning the device, and the movement of the catheter was not as smooth as usual.The catheter was then withdrawn for inspection, wherein a crack was observed on the distal portion of the catheter shaft.Another of the same device was used, and the procedure was completed successfully without patient complications.The device has been received and analyzed.

• 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: 23956642
• Report Number: 2124215-2026-00238
• Device Sequence Number: 9610634
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: (01)08714729877615(17)280820(10)37264314
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0042011010
• Device Catalogue Number: M0042011010
• Device Lot Number: 0037264314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Patient Sex: Unknown