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

Model Number	86706
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection found the device has a kink on the shaft, also the tip is detached from the shaft with no adhesive residues observed.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The test curve passes; the curve is less than the specification of 4.5cm.The curve also passes the out-of-plane test.The device passed the dimensional test.Microscope inspection found the tip is out of the shaft and no adhesive residues were observed.X-ray inspection showed tip detachment confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on device analysis completed on 21oct2021.It was reported that before a procedure to treat atrial fibrillation a dynamic xt catheter was selected for use.The shaft was bent while removing the packaging, the package was in good conditions.The issue was solved by exchanging the catheter and the procedure was successfully completed with no patient complications.However, device analysis revealed the tip was detached from the shaft.

• 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: 12790392
• Report Number: 2134265-2021-14189
• Device Sequence Number: 20040953
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 04/01/2023
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0025430677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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