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

Model Number	M0046DYNTP0010
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the catheter tip was fractured.During a radiofrequency ablation procedure to treat atrial arrhythmia in the left atrium, a dynamic tip electrode catheter was used.When attempting to insert the catheter, it was observed that the tip was fractured.Another dynamic tip electrode catheter was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition was stable following the procedure.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that the catheter tip was fractured.During a radiofrequency ablation procedure to treat atrial arrhythmia in the left atrium, a dynamic tip electrode catheter was used.When attempting to insert the catheter, it was observed that the tip was fractured.Another dynamic tip electrode catheter was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition was stable following the procedure.The device has been received and analyzed.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this dynamic tip electrode catheter was visually inspected, and it was found that the plunger was broken.Product analysis did not confirm the reported event of tip damaged/defective.The investigation concluded that the device problem of tip damaged/defective was excluded, as the findings indicate that there was no problem with the tip of the device.Additionally, an investigation to address the observed event of broken plunger is in progress.

• Brand Name: DYNAMIC TIP
• 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: 23671761
• Report Number: 2124215-2025-86058
• Device Sequence Number: 9984067
• Product Code: DRF
• UDI-Device Identifier: 08714729879848
• UDI-Public: (01)08714729879848(17)271212(10)35474922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K912213
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: M0046DYNTP0010
• Device Catalogue Number: M0046DYNTP0010
• Device Lot Number: 0035474922
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG