MAUDE Adverse Event Report: BOSTON SCIENTIFIC - BURLINGTON NITINOL TC ELECTRODE; PROBE, RADIOFREQUENCY LESION

Model Number	TCN-10
Medical Device Problem Codes	Break (1069); Material Discolored (1170); Material Separation (1562); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A total of (3) electrodes were returned: quantity (1) - tcn-10, lot 121415 quantity (2) ¿ tcn-10, lot 122815 additional suspect medical device components involved in the event: model: tcn-10 lot: 122815 description: nitinol tc electrode, 100 mm.
Event or Problem Description
The device analysis performed on the (1) returned electrode tcn-10, lot 121415 revealed that the shaft of the electrode was found to be completely separated from the hub due to excessive external mechanical force.The shaft was not returned for analysis.The functional test could not be performed due to the separated shaft.Visual inspection also revealed discolored epoxy and a chip out.The color of newly cured epoxy is amber, light brown.If the epoxy is subjected to too many autoclave cycles it becomes brittle and discolored.This failure mechanism is due to external mechanical force and thermal stress associated with multiple autoclave cycles.The device analysis performed on the (2) tcn-10, lot 122815 revealed discolored epoxy and a chip out.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC - BURLINGTON; 22 terry ave; burlington MA 01803
• MDR Report Key: 7578107
• Report Number: 3006630150-2018-02059
• Device Sequence Number: 18884442
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: Physician
• Device Model Number: TCN-10
• Device Lot Number: 121415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1