BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 2151513 · Received June 21, 2011

    Report

    Report Number
    2184149-2011-00007
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    MTD
    PMA / PMN Number
    K983456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL NUMBER IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HOLE IN THE ENSITE ARRAY CATHETER BALLOON DURING AN ABLATION PROCEDURE. NEAR THE END OF AN ABLATION PROCEDURE, THE PHYSICIAN NOTICED ON FLUOROSCOPY THAT THE BALLOON OF THE ENSITE ARRAY CATHETER HAD DEFLATED. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT AND ATTEMPTED TO INFLATE THE CATHETER WITH A SALINE SYRINGE AND NOTED THERE WAS A SMALL HOLE IN THE BALLOON. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITH THE CONVENTIONAL APPROACH WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER HIGH-DENSITY ARRAY CATHETER MTD ST. JUDE MEDICAL, AF DIVISION EC1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR