MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) NEUROTHERM¿ CLASSIC STRAIGHT RF NEEDLE, 18G, 10CM; PROBE, RADIOFREQUENCY LESION

Model Number	S-1010-18
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cannula coating had melted.As such, the rf procedure was not completed.The procedure was converted to anesthetic block to address the issue.
Additional Manufacturer Narrative
A cannula needle experiencing a temperature decomposition issue was reported to abbott.The results of the investigation are inconclusive as the device was discarded by the hospital and not returned for evaluation.As a result, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Additional Manufacturer Narrative
A cannula needle experiencing a melting issue was reported to abbott; however, the allegation was not confirmed.The results of the investigation are inconclusive as the device was discarded by the hospital and not returned for evaluation.The attached video shows the cannula insulation adjacent toward the needle tip was pushed back and bunched up away from its intended location.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined, however is consistent with accidental damage during use.Per the investigation finding the medical device problem code (h6) was updated.

• Brand Name: NEUROTHERM¿ CLASSIC STRAIGHT RF NEEDLE, 18G, 10CM
• Common Device Name: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21020809
• Report Number: 3005334138-2024-00559
• Device Sequence Number: 18430726
• Product Code: GXI
• UDI-Device Identifier: 05415067028617
• UDI-Public: (01)05415067028617(10)10061255(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: S-1010-18
• Device Catalogue Number: S-1010-18
• Device Lot Number: 10061255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 02/13/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/17/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: Other
• Patient Sex: Unknown