BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 23816634 · Received December 16, 2025

    Report

    Report Number
    1717344-2025-01606
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    July 10, 2025
    Report Date
    May 29, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E1(PREFIX), H11(LITERATURE CITATION) MARWAN MOUSSA, MD, OMAR HAMAM, MD, AHMAD MAALY, MD, MOHAMMED ELKHOLY, MD, MOHAMED FARGHALY, MD, GODWIN ABIOLA, MD, SALOMAO FAINTUCH, MD, BARRY SACKS, MD, ANAND VAIDYA, MD, MUNEEB AHMED, MD, AND AMMAR SARWAR, MD THE ALDOSTERONOMA RESOLUTION SCORE AS A PREDICTIVE METRIC FOR OUTCOMES AFTER RADIOFREQUENCY ABLATION FOR PRIMARY ALDOSTERONISM. SIR, 2025 J VASC INTERV RADIOL 2025; 36:1705¿1713; HTTPS://DOI.ORG/10.1016/J.JVIR.2025.07.011 ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN COOL TI, UNKNOWN COOL TIP ELECRTRODE (LOT #: UNKNOWN) (B)(6). THE ALDOSTERONOMA RESOLUTION SCORE AS A PREDICTIVE METRIC FOR OUTCOMES AFTER RADIOFREQUENCY ABLATION FOR PRIMARY ALDOSTERONISM. 2025. HTTPS://DOI.ORG/10.1016/J.JVIR.2025.07.011. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCO.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, AN OBSERVATION AND RETROSPECTIVE STUDY WAS USED TO VALIDATE THE ALDOSTERONOMA RESOLUTION SCORE (ARS) AS A PROGNOSTICATOR FOR BIOCHEMICAL AND CLINICAL OUTCOMES FOLLOWING RADIOFREQUENCY (RF) ABLATION FOR THE TREATMENT OF PRIMARY ALDOSTERONISM (PA). THE STUDY USED A 15 CM LONG COOL-TIP ABLATION ELECTRODE UNDER CT GUIDANCE TO PERCUTANEOUSLY ABLATE THE ADRENAL NODULE. 59 PATIENTS WERE INCLUDED IN THIS STUDY WHO UNDERWENT RF ABLATION FROM 2007 TO 2023. THE TECHNICAL SUCCESS RATE ACHIEVED WAS 100% IN ALL PATIENTS; HOWEVER, 1 PATIENT DID DEVELOP A LEFT PERINEPHRIC HEMATOMA. THE ALDOSTERONOMA RESOLUTION SCORE AS A PREDICTIVE METRIC FOR OUTCOMES AFTER RADIOFREQUENCY ABLATION FOR PRIMARY ALDOSTERONISM, (B)(6), ARS AS A PREDICTOR OF OUTCOMES POST RFA IN PA, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140350 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1