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

Model Number TCN-10

Device Problems Break (1069); Material Discolored (1170); Material Separation (1562); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2018

Event Type  malfunction  

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 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
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC - BURLINGTON; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7578107
• MDR Text Key: 110359754
• Report Number: 3006630150-2018-02059
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1