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

Model Number	CSK-TC10
Medical Device Problem Codes	Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: gxd, gxi.
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.Additional information was received that the lot number was previously incorrect and a different lot number was confirmed.
Event or Problem Description
It was reported that the patient underwent a radiofrequency ablation (rfa) procedure during which an electrode became detached from the connector while inside the patient.The outcome of the procedure was unable to be obtained.Additional information was received that the lot number was previously incorrect and a different lot number was confirmed.After further review, the broken electrode was discovered post-procedure and did not occur inside the patient.As such, there was no reported patient harm.
Additional Manufacturer Narrative
Device analysis performed on the returned electrode revealed that it would not register temperature during functional testing.An x-ray inspection confirmed that a fractured wire in the hub caused an open circuit.This damage is indicative of fatigue from overuse of the electrode.A labeling review was conducted which determined that the electrode should not be sharply bent, as documented in the instructions for use (ifu).Therefore, engineers concluded that this damage to the electrode was due to the device design.B3: approximated based on the date the manufacturer became aware of the event.D2b: gxd, gxi.

• Brand Name: NA
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19966545
• Report Number: 3006630150-2024-05263
• Device Sequence Number: 8898067
• Product Code: GXD
• UDI-Device Identifier: 00813250010107
• UDI-Public: 00813250010107
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2024

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 Model Number: CSK-TC10
• Device Catalogue Number: CSK-TC10
• Device Lot Number: 31309592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 12/06/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/08/2024; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown