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	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation of an ablation procedure to treat a supraventricular tachycardia (svt), a dynamic xt steerable diagnostic catheter was selected for use.On opening sterile packaging, scout nurse identified a small fiber that appeared to represent a hair/strand of glue attached near a join toward the end of the black section of the handle.Device was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter has been received for analysis.
Additional Manufacturer Narrative
Dynamic xt steerable diagnostic catheter was evaluated by boston scientific.Upon receipt at our post market quality assurance laboratory, analysis of returned product revealed that the device has hair/strand of glue attached near a join, also the device has few kinks in the shaft, the first one in the plunger, the second one is 8cm from the plunger, the third one is 8cm from the tip., consequently confirming the reported clinical observation of foreign material.Based on all available information, boston scientific's investigation findings determined failure might have been caused due to an inspection / verification during the manufacturing process.
Event or Problem Description
It was reported that during the preparation of an ablation procedure to treat a supraventricular tachycardia (svt), a dynamic xt steerable diagnostic catheter was selected for use.On opening sterile packaging, scout nurse identified a small fiber that appeared to represent a hair/strand of glue attached near a join toward the end of the black section of the handle.Device was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter has been received for analysis.

• 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: 19957764
• Report Number: 2124215-2024-48602
• Device Sequence Number: 8801837
• Product Code: DRF
• UDI-Device Identifier: 08714729877622
• UDI-Public: 08714729877622
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/15/2024

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: 09/28/2026
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0032532664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown