MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) REUSABLE ELECTRODE, 10CM, SST; RFA PROBE

Model Number	RF-SE-10
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that during an ablation procedure the patient experienced a secondary burn at the site of probe insertion.Reportedly, the burn was diagnosed months later and the wound is being treated with epson salt compresses and medical honey.
Additional Manufacturer Narrative
The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: rfa probe, model: rf-se-10 , udi: (b)(4), serial: (b)(6), batch: m18993.
Event or Problem Description
Additional information received indicates that the burn was only at one site of insertion.Investigation was unable to determine which of the probe attributed to the issue.
Additional Manufacturer Narrative
Device analysis: model: rf-se-10 , serial: (b)(6).During visual inspection it was noted that the stainless steel probe had been bent approxiamtley 10, from the distal end of the hub., no anomalies were noted to the hub, cable, or connector.During minta's failure analysis of this device the following tests were performed: loop test to check for any broken wires using a calibrated resistance meter, this test also includes robust manipulation of the probe and wires to check for any intermittent breaks.Results - passed.Functional test, this is were the probe is checked against a thermocouple standard in a fixed temperature bath of 80°c using a calibrated temperature thermometer.Results - passed dimensional test to check the dimension and condition of the probe for any damage.Results - passed despite multiple testing and manipulation no faults were found.Model: rf-se-10 , serial: (b)(6): during visual inspection it was noted that the stainless steel probe had been bent approximately 15, 15mm from the end of the tip, see image 1.No anomalies were noted to the hub, cable, or connector.During minta's failure analysis of this device the following tests were performed: loop test to check for any broken wires using a calibrated resistance meter, this test also includes robust manipulation of the probe and wires to check for any intermittent breaks.Results - passed.Functional test, this is were the probe is checked against a thermocouple standard in a fixed temperature bath of 80° c using a calibrated temperature thermometer.Results - passed dimensional test to check the dimension and condition of the probe for any damage.Results - passed.Despite multiple testing and manipulation no faults were found.

• Brand Name: REUSABLE ELECTRODE, 10CM, SST
• Common Device Name: RFA PROBE
• 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: 17890360
• Report Number: 3005334138-2023-00457
• Device Sequence Number: 7551916
• Product Code: GXD
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2024

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: RF-SE-10
• Device Lot Number: M18993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 03/01/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/01/2023; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: Female
• Patient Weight: 50 KG