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

Model Number RFK-C10520S

Device Problems Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

It was reported that the facility received four incorrectly labeled boxes of cannulas.

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
• Type of Device: 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
• MDR Text Key: 283390546
• Report Number: 3006630150-2021-07496
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250012033
• UDI-Public: 00813250012033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1