BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER

    MDR report key: 21112033 · Received January 9, 2025

    Report

    Report Number
    2030404-2025-00001
    Event Type
    Injury
    Date Received
    January 9, 2025
    Report Date
    January 9, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HIGH BLOOD PRESSURE & CARDIOVASCULAR PREVENTION (2024) 31:687¿694 "BLOOD PRESSURE CONTROL AND CLINICAL OUTCOMES AFTER RENAL DENERVATION THROUGH IRRIGATED CATHETER RADIOFREQUENCY ABLATION IN PATIENTS WITH RESISTANT HYPERTENSION: A CASE SERIES WITH UP TO 10 YEARS OF FOLLOW-UP"; LUNA VARELA DO CARMO WE EVALUATED PATIENTS WITH RESISTANT HYPERTENSION (RH) WHO UNDERWENT RDN WITH IRRIGATED CATHETER FROM 2012 TO 2014 AT A SINGLE CENTRE. OFFICE BLOOD PRESSURE (BP) AND 24-HOUR AMBULATORY BP WERE ASSESSED. CLINICAL EVENT (STROKE, MYOCARDIAL INFARCTION, NEED FOR DIALYSIS, OR DEATH FROM ANY CAUSE), LEFT VENTRICULAR MASS INDEX (LVMI), ESTIMATED GLOMERULAR FILTRATION RATE (EGFR), AND URINE ALBUMIN-TO-CREATININE RATIO (UACR) WERE EVALUATED. THE ANALYSIS INCLUDED 20 INDIVIDUALS (AGE 51, 75% FEMALE, AMBULATORY SYSTOLIC BP (SBP) 168 MMHG, AMBULATORY DIASTOLIC BP (DBP) 101 MMHG, TAKING 7 ANTIHYPERTENSIVE MEDICATIONS). THE MEDIAN FOLLOW-UP PERIOD WAS 8.5 YEARS. MEAN CHANGES FROM BASELINE WERE: -47 MMHG FOR OFFICE SBP, -25 MMHG FOR OFFICE DBP, -29 MMHG FOR AMBULATORY SBP, AND -15 MMHG FOR AMBULATORY DBP. THE NUMBER OF ANTIHYPERTENSIVE DRUGS MARKEDLY DECREASED ONE MONTH AFTER RDN AND A GRADUAL UPWARD TREND WAS OBSERVED OVER TIME. A CLINICAL EVENT OCCURRED IN 9 PARTICIPANTS. LVMI DECREASED, THE EGFR DECLINED, AND THE UACR DID NOT SIGNIFICANTLY CHANGE FROM BASELINE TO FOLLOW-UP. IT WAS REPORTED THAT A PATIENT HAD A DISSECTION OF THE RIGHT RENAL ARTERY AFTER THE ABLATION DUE TO MECHANICAL DAMAGE CAUSED BY THE SHEATH. THE DISSECTION WAS TREATED WITH STENT IMPLANTATION AND THE PATIENT DID NOT HAVE ANY FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365222 THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER catheter, percutaneous, cardiac ablation, for treatment of atrial flutter OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R