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

Model Number	RFK-C101018S-ZK2-P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the physician went to remove the from the electrode and felt a lot of resistance.The physician eventually was able to remove it, however, the bottom portion of the probe was stripped, and the wires were exposed.X-ray was taken d confirmed that there was still a piece of the probe left inside the patient.They agreed that because the piece is sterile and very small it should not cause the patient any issues.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Device technical analysis: the returned cannula was analyzed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that during a surgery the physician went to remove cannula the from the electrode and felt a lot of resistance.The physician eventually was able to remove it, however, the bottom portion of the probe was stripped, and the wires were exposed.X-ray was taken and confirmed that there was still a piece of the probe left inside the patient.They agreed that because the piece is sterile and very small it should not cause the patient any issues.The patient was doing well postoperatively.

• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13162507
• Report Number: 3006630150-2022-00008
• Device Sequence Number: 11799185
• Product Code: GXI
• UDI-Device Identifier: 00191506013684
• UDI-Public: 00191506013684
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/16/2023
• Device Model Number: RFK-C101018S-ZK2-P
• Device Catalogue Number: RFK-C101018S-ZK2-P
• Device Lot Number: 28213483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown