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

Model Number	CUR-101020U
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency ablation procedure the cannula broke away from the electrode during the placement of the probe and became embedded in the patient.The device was removed and the procedure was completed.The patient is recovering.
Additional Manufacturer Narrative
Engineers inspected and analyzed the device upon receipt; the shaft of the electrode was determined to be fully separated from the hub.The hub was disassembled, and proper adhesive curing was observed within the hub; no issues were found in the bonding of the cannula within the hub.It was further determined that manufacturing process did not contribute to the reported event.Engineers determined that the cannula braking away from the electrode was caused by unintended error in the use of the device which caused or contributed to the event.
Event or Problem Description
It was reported that during a radiofrequency ablation procedure the cannula broke away from the electrode during the placement of the probe and became embedded in the patient.The device was removed and the procedure was completed.The patient is recovering.

• Brand Name: NA
• 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: 15070774
• Report Number: 3006630150-2022-03586
• Device Sequence Number: 5377461
• Product Code: GXI
• UDI-Device Identifier: 00813250016642
• UDI-Public: 00813250016642
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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 Expiration Date: 11/28/2025
• Device Model Number: CUR-101020U
• Device Catalogue Number: CUR-101020U
• Device Lot Number: 28458504
• 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: 06/25/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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