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

Model Number	86706
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a procedure using a dynamic xt catheter the shaft of the sheath was broken.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and it was found the plunger that controls the steering of the catheter had separated from the rest of the handle.The reported allegation of irrigation failure was confirmed, however, the root cause for the break could not be determined from the information provided from the site or from examining the damaged device.
Event or Problem Description
It was reported that during preparation for a procedure using a dynamic xt catheter the shaft of the sheath was broken.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter has been received 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17270174
• Report Number: 2124215-2023-34168
• Device Sequence Number: 7911776
• Product Code: DRF
• UDI-Device Identifier: 08714729877622
• UDI-Public: 08714729877622
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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 Expiration Date: 11/04/2025
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0030486967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• 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