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

Model Number	86706
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The dynamic xt electrode catheter was selected for use during the procedure.It was reported that when the outer package of the device was removed, they found the plastic protective sleeve outside the catheter was fractured.The device was contaminated and could not be used due to damage to the protective sleeve.Catheter was replaced with a new one from the same model.Procedure was completed successfully without patient complications.The device is expected to be returned 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
An image was reviewed by a boston scientific quality engineer.The image shows evidence that the device packaging was damaged, consequently, confirming the reported complaint since failure might have been caused due to a bad manipulation or wrong handling during the transport of the unit.
Event or Problem Description
The dynamic xt electrode catheter was selected for use during the procedure.It was reported that when the outer package of the device was removed, they found the plastic protective sleeve outside the catheter was fractured.The device was contaminated and could not be used due to damage to the protective sleeve.Catheter was replaced with a new one from the same model.Procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
Event or Problem Description
The dynamic xt electrode catheter was selected for use during the procedure.It was reported that when the outer package of the device was removed, they found the plastic protective sleeve outside the catheter was fractured.The device was contaminated and could not be used due to damage to the protective sleeve.Catheter was replaced with a new one from the same model.Procedure was completed successfully without patient complications.The device was returned for analysis.
Additional Manufacturer Narrative
The dynamic xt electrode catheter was evaluated by boston scientific.Upon receipt at the laboratory analysis, analysis of returned product revealed that the device has few kinks in the shaft, located 18cm from the tip and 27cm from the tip.Also, an image shows evidence that the device packaging was damaged, consequently, confirming the reported complaint since failure might have been caused due to a bad manipulation or wrong handling during the transport of the unit.

• Brand Name: DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20488681
• Report Number: 2124215-2024-65082
• Device Sequence Number: 3554005
• Product Code: DRF
• UDI-Device Identifier: 08714729877622
• UDI-Public: 08714729877622
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/08/2025

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 Expiration Date: 06/06/2026
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0031775103
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 12/16/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/26/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown