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

Model Number RF-SE-10

Device Problems Thermal Decomposition of Device (1071); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 325143910
• Report Number: 3005334138-2023-00457
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 50 KG