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	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was difficult to withdraw and difficult to advance.During a procedure to treat a supraventricular tachycardia at sinus coronarius, a dynamic xt catheter was selected for use.It was observed that the catheter went entrapped in a side branch to sinus coronarius.It could not be withdrawn or pushed forward.The catheter had to be rotated counterclockwise to be removed.There was a noticeable damage at the tip between the distal tip electrode and pole 2, it looks like the diameter is slightly larger, it wasn't sure if that defect was created after the catheter got stuck and they tried to rotate it out.If this defect was there from the beginning, no one knows.The physician didn't have trouble inserting the device.It was 5 or 6 f of the sizes and types of sheaths.Catheter was replaced and the issue was resolved.The procedure was completed with a non-bsc product.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, this dynamic xt electrode catheter was visually inspected, and no visual damage was observed.Functional testing revealed that the catheter functional mechanism worked properly; no abnormal resistance was felt when the device was actuated.Media inspection on the photo provided was unable to confirm the reported events of difficult to withdraw and difficult to advance.With all available information, the complaint could not be confirmed as the reported events were not able to be reproduced, and the device presented with no issues.
Event or Problem Description
It was reported that the catheter was difficult to withdraw and difficult to advance.During a procedure to treat a supraventicular tachycardia at sinus coronarius, a dynamic xt catheter was selected for use.It was observed that the catheter went entrapped in a side branch to sinus coronarius.It could not be withdrawn or pushed forward.The catheter had to be rotated counterclockwise to be removed.There was a noticeable damage at the tip between the distal tip electrode and pole 2, it looks like the diameter is slightly larger, it wasn't sure if that defect was created after the catheter got stuck and they tried to rotate it out.If this defect was there from the beginning, no one knows.The physician didn't have trouble inserting the device.It was 5 or 6 f of the sizes and types of sheaths.Catheter was replaced and the issue was resolved.The procedure was completed with a non-bsc product.There were no patient complications.The device is expected to be return 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: 21928403
• Report Number: 2124215-2025-26620
• Device Sequence Number: 9086634
• 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): 07/08/2025

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: 06/13/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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