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

Model Number	TCN-10
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that the hub separated from the electrode while it was being washed.
Event or Problem Description
A report was received that the hub separated from the electrode while it was being washed.
Additional Manufacturer Narrative
The explanted devices were not returned to bsn as they were kept by the medical facility.A review of the manufacturing documentation for the product revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8713822
• Report Number: 3006630150-2019-02897
• Device Sequence Number: 2004016
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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 Model Number: TCN-10
• Device Catalogue Number: TCN-10
• Device Lot Number: 23297089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1