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

Model Number	M0042011030
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• 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: 50115122
• Report Number: 2124215-2026-41429
• Device Sequence Number: 10076151
• Product Code: DRF
• UDI-Device Identifier: 08714729877639
• UDI-Public: (01)08714729877639(17)270307(10)33583927
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/02/2026

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: M0042011030
• Device Catalogue Number: M0042011030
• Device Lot Number: 0033583927
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 03/07/2024
• 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 Sex: Unknown