BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDO ADVANCE

    MDR report key: 2173777 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10582
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEADS REMAIN IN SERVICE AND THE CATHETER WILL NOT BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THIS PATIENT WAS SCALED DOWN FOR CONTRACTION PERFORMANCE AND BLOOD PRESSURE PERFORMANCE. A REVIEW OF A ECHOCARIOGRAPH CONFIRMED THE PATIENT HAD DEVELOPED A CARDIAC TAMPONADE. PRECARDIOCENTESIS WAS DONE WITH 450 CC BLOOD DEPLETION. THE TEMPONADE WAS SUSPECTED TO BE CAUSED BY A PERFORATION OF A RAPIDO GUIDING CATHETER. IN ADDITION, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND WAS SUCCESSFULLY CONVERTED WITH A DEFIBRILALTION SHOCK DURING THE IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. AT THIS TIME, THE CATHETER WILL NOT BE RETURNED FOR ANALYSIS. DEVICE AND LEADS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDO ADVANCE DYB GUIDANT PUERTO RICO BV 7713

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening