MAUDE Adverse Event Report: ABBOTT MEDICAL (AF-MINNETONKA) CURVED 10CM LONG 10MM TIP 20G; RFA NEEDLE

Model Number	SMK-C1010-20
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an rfa procedure the physician noticed that once the needle was removed from the patient the white coating was missing.The patient did not experience any negative effects as a result.
Additional Manufacturer Narrative
The date of event is estimated.

• Brand Name: CURVED 10CM LONG 10MM TIP 20G
• Common Device Name: RFA NEEDLE
• Manufacturer (Section D): ABBOTT MEDICAL (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ABBOTT MEDICAL (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 25015805
• Report Number: 2182269-2026-00234
• Device Sequence Number: 18518102
• Product Code: GXI
• UDI-Device Identifier: 05415067028730
• UDI-Public: (01)05415067028730(10)11046718(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K000073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SMK-C1010-20
• Device Catalogue Number: SMK-C1010-20
• Device Lot Number: 11046718
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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