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

Model Number	RFK-C10520S
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the facility received four incorrectly labeled boxes of cannulas.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: rfa-cannulas, upn: rfk-c10520s, model: rfk-c10520s, serial: null, batch: 27447862.Product family: rfa-cannulas, upn: rfk-c10520s, model: rfk-c10520s, serial: null, batch: 27447862.Product family: rfa-cannulas, upn: rfk-c10520s, model: rfk-c10520s, serial: null, batch: 27447862.The four boxes of cannulas were returned and inspected and it was confirmed that the tip of the cannulas measured 10mm and the label on the packaging is for a 5mm tip.

• 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: 13183450
• Report Number: 3006630150-2021-07496
• Device Sequence Number: 16661897
• Product Code: GXI
• UDI-Device Identifier: 00813250012033
• UDI-Public: 00813250012033
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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: Other
• Device Expiration Date: 06/06/2025
• Device Model Number: RFK-C10520S
• Device Catalogue Number: RFK-C10520S
• Device Lot Number: 27447862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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
• Patient Sex: Unknown