MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION RFA-ELECTRODES-REUSABLE; PROBE, RADIOFREQUENCY LESION

Model Number	CSK-TC15
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that the electrode was broke at the hub during a procedure.The patient was not harmed and the procedure was completed with a different electrode.
Additional Manufacturer Narrative
A review of the manufacturing documentation for the electrode revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the electrode was broke at the hub during a procedure.The patient was not harmed and the procedure was completed with a different electrode.

• Brand Name: RFA-ELECTRODES-REUSABLE
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7753184
• Report Number: 3006630150-2018-60490
• Device Sequence Number: 19148191
• Product Code: GXI
• UDI-Device Identifier: 00813250010114
• UDI-Public: 0813250010114
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/02/2018

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: Health Professional
• Device Model Number: CSK-TC15
• Device Catalogue Number: CSK-TC15
• Device Lot Number: L203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1