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

Model Number CUR-101018

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Device analysis performed on the returned electrode revealed that the electrode passed visual inspection.However, when alcohol was attempted to be pushed through the injection port, it could not be pushed through due to a solidified blood clot, which caused an obstruction inside the hub.

• 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: 13389589
• MDR Text Key: 285035440
• Report Number: 3006630150-2022-00235
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250016963
• UDI-Public: 00813250016963
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUR-101018
• Device Catalogue Number: CUR-101018
• Device Lot Number: 27479944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2021
• 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