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

Model Number	TCN-15
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: tcn-10, serial/lot: (b)(4), description: nitinol tc electrode: 10 cm.
Event or Problem Description
A report was received that the facility was unable to clean 3 probes due to the hub leaking at the base of the probe.The facility claims that it was blood leaking out of the hub.
Event or Problem Description
A report was received that the facility was unable to clean 3 probes due to the hub leaking at the base of the probe.The facility claims that it was blood leaking out of the hub.
Additional Manufacturer Narrative
The returned electrodes tcn-15 lot # 23376542, tcn-10 lot # 23797361, and tcn-10 lot# 22807295 were analyzed and it was determined that the material found on the hubs contained proteins like those found in blood.Overuse of the electrodes, such as 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, which can lead to cracks that allow for fluid ingress.With all the available information, boston scientific concludes the reported event was confirmed.The probable cause is due to failure to follow instructions.The electrodes were likely sterilized beyond the (b)(4) sterilizations cycles that they are validated for.

• 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: 8876322
• Report Number: 3006630150-2019-04157
• Device Sequence Number: 2389969
• Product Code: GXI
• UDI-Device Identifier: 00813250013061
• UDI-Public: 00813250013061
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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-15
• Device Catalogue Number: TCN-15
• Device Lot Number: 23376542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1