BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY¿ ABLATION CATHETER

    MDR report key: 8925750 · Received August 23, 2019

    Report

    Report Number
    2030404-2019-00079
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P040042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE PORTUGUESE SOCIETY OF CARDIOLOGY IN AN ARTICLE TITLED ¿ATRIOVENTRICULAR NODE REENTRANT TACHYCARDIA: REMOTE MAGNETIC NAVIGATION ABLATION VERSUS MANUAL ABLATION --- IMPACT ON OPERATOR FLUOROSCOPY TIME BY PARREIRA L, MARINHEIRO R, CARMO P, ET AL., 09 APRIL 2019; 38(3):187-192. ¿WE SELECTED 139 CONSECUTIVE PATIENTS UNDERGOING AVNRT ABLATION WITH MAGNETIC NAVIGATION BY A SINGLE OPERATOR BETWEEN JANUARY 2009 AND JUNE 2016 AND COMPARED THEM TO A GROUP OF 101 CONSECUTIVE PATIENTS UNDERGOING MANUAL ABLATION IN THE SAME PERIOD BY THE SAME OPERATOR IN ANOTHER HOSPITAL. THE METHODOLOGY WAS THE SAME IN BOTH GROUPS. SUCCESS RATES, COMPLICATIONS, PROCEDURE TIME, RADIOFREQUENCY TIME, TOTAL AND OPERATOR FLUOROSCOPY TIME, AND RECURRENCE RATES WERE COMPARED. ABLATION WAS SUCCESSFUL IN ALL PATIENTS IN BOTH GROUPS. RF DELIVERY WAS INTERRUPTED IN ONE PATIENT DUE TO TRANSIENT SECOND-DEGREE AV BLOCK, WHICH DISAPPEARED WITHIN SECONDS OF RF INTERRUPTION. NO CHARRING WAS FOUND ON THE CATHETER TIP. THERE WERE NO OTHER PROCEDURE-RELATED COMPLICATIONS.¿ (HTTPS://DOI.ORG/10.1016/J.REPC.2018.07.006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718873 THERAPY¿ ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other