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

Model Number	TCN-10
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that an electrode was found to have residual blood left inside the probe where the wire connects after multiple uses.The residual blood was noticed after being cleaned.
Additional Manufacturer Narrative
The device analysis confirmed the complaint.Overuse of the electrodes (sterilizing units beyond the number of cycles the units are validated for) can lead to additional wear on the units and the epoxy inside the hub, leading to cracks that allow for fluid ingress.The lab determined that the material found on the hub contained proteins like those found in blood.
Event or Problem Description
A report was received that an electrode was found to have residual blood left inside the probe where the wire connects after multiple uses.The residual blood was noticed after being cleaned.

• Brand Name: NA
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8798632
• Report Number: 3006630150-2019-03617
• Device Sequence Number: 11383899
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1