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

Model Number	M0042011010
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficult to withdraw and difficult to advance.During radio frequency procedure to treat atrial flutter at side branch to the sinus coronarius, a dynamic xt was selected for use.It was observed that the catheter was entangled in a side branch to the sinus coronarius.When the catheter was removed, there was some kind of defect between electrodes 1 and 2 and it got stuck in a side branch to sinus coronarius and it couldn't get it out.No resistance felt while maneuvering the catheter.The procedure was completed.There were no patient complications.The device is expected to be return 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
Upon receipt at our post market quality assurance laboratory, this dynamic xt electrode catheter was visually inspected, and no visual defects were noted.Functional testing showed that the catheter's functional mechanism worked properly; no abnormal resistance was felt when actuating the device.Media inspection on the photo provided could not confirm the reported events of catheter difficult to withdraw and difficult to advance.With all available information, the reported events could not be confirmed as the reported failures were not able to be reproduced, and the device presented with no issues.
Event or Problem Description
It was reported that difficult to withdraw and difficult to advance.During radio frequency procedure to treat atrial flutter at side branch to the sinus coronarius, a dynamic xt was selected for use.It was observed that the catheter was entangled in a side branch to the sinus coronarius.When the catheter was removed, there was some kind of defect between electrodes 1 and 2 and it got stuck in a side branch to sinus coronarius and it couldn't get it out.No resistance felt while maneuvering the catheter.The procedure was completed.There were no patient complications.The device was returned for analysis.

• 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: 21928645
• Report Number: 2124215-2025-26622
• Device Sequence Number: 9086169
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: (01)08714729877615(17)271212(10)35481877
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/11/2025

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: 0035481877
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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 Sex: Unknown