BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY ABLATION CATHETER, SENSOR ENABLED

    MDR report key: 12056873 · Received June 24, 2021

    Report

    Report Number
    3008452825-2021-00353
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    OAD
    UDI-DI
    05415067020086
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A TYPICAL CAVO-TRICUSPID ISTHMUS (CTI) ATRIAL FLUTTER ABLATION PROCEDURE, A STEAM POP AND PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING A LINE FROM THE TRICUSPID VALVE TOWARDS THE INFERIOR VENA CAVA NO IMPEDANCE RISE WAS NOTED, BUT A THERE WAS A FAINT AUDIBLE STEAM POP. THE LESION WAS COMPLETED SUCCESSFULLY BUT A FEW MINUTES LATER THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953236 FLEXABILITY ABLATION CATHETER, SENSOR ENABLED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL, COSTA RICA LTDA A-FASE-FJ 7778658 05415067020086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention