BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 2152593 · Received June 27, 2011

    Report

    Report Number
    2184149-2011-00009
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    MTD
    PMA / PMN Number
    K983456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER ARRAY WAS BROUGHT TO FULL PROFILE AND THE BALLOON WAS INFLATED. THERE WAS A LEAK OBSERVED IN THE BALLOON. THE BALLOON WAS EXAMINED UNDER MAGNIFICATION AND THERE WAS AN OBLONG HOLE APPROXIMATELY .003" WIDE BY .01" IN LENGTH BETWEEN THE FIFTH AND SIXTH COLUMN OF ELECTRODES. BOTH OF THESE ELECTRODES HAD MATERIAL ALTERCATIONS SIMILAR TO THAT OF A CATHETER THAT WAS IN CLOSE PROXIMITY TO AN ABLATION CATHETER AT THE TIME OF RADIOFREQUENCY THERAPY DELIVERY. 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 A LEAK DEVELOPED IN THE BALLOON OF THE ENSITE ARRAY CATHETER DURING AN ELECTROPHYSIOLOGICAL MAPPING PROCEDURE. THE PHYSICIAN WAS USING AN ENSITE ARRAY CATHETER FOR AN ELECTROPHYSIOLOGICAL MAPPING PROCEDURE WHEN IT WAS NOTED THAT CONTRAST AND SALINE SOLUTION WAS LEAKING FROM THE CATHETER BALLOON INTO THE PATIENT. THE ENSITE ARRAY CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED 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 3242059

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR