MAUDE Adverse Event Report: ABBOTT MEDICAL (AF-MINNETONKA) STRAIGHT 10CM LONG 10MM TIP 22G; RFA NEEDLE

Model Number	SMK-S1010-22
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.A cannula experiencing damage to its insulation layer was reported to abbott; however, the device was not returned for evaluation.Post-procedural evaluation identified the cracked insulation sheathing and the issue was confirmed via attached photos.A review of documentation supplied with the cannula states that cannulae should not be bent or folded, as this may cause insulation damage.Based on the information received, the cause of the reported incident is consistent with an overstress situation that would have caused accidental damaged to the insulation layer.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.
Event or Problem Description
It was reported after the radio frequency treatment was completed, an instrument count revealed that the cannula used during the procedure had part of its insulation layer missing on the portion inserted into the patient¿s body.The treatment was completed and patient remained stable.

• Brand Name: STRAIGHT 10CM LONG 10MM TIP 22G
• 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: 24011128
• Report Number: 2182269-2026-00001
• Device Sequence Number: 9250219
• Product Code: GXI
• UDI-Device Identifier: 05415067028792
• UDI-Public: (01)05415067028792(10)10876874(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/08/2026

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-S1010-22
• Device Catalogue Number: SMK-S1010-22
• Device Lot Number: 10876874
• 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: 12/11/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown