BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE VELOCITY SYSTEM

    MDR report key: 2182221 · Received July 12, 2011

    Report

    Report Number
    2184149-2011-00012
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    MTD
    PMA / PMN Number
    K983456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ENSITE ARRAY BALLOON WAS INFLATED AND A PIN SIZED HOLE WAS OBSERVED. THE BALLOON WAS DEFLATED AND THE ARRAY WAS BROUGHT BACK TO LOW PROFILE. THE HOLE IN THE BALLOON WAS EXAMINED AND FOUND TO BE OVAL IN SHAPE MEASURING .005 INCHES BY .007 INCHES LOCATED JUST DISTAL OF THE ARRAY IN THE SECOND ROW. THE EDGES OF THE HOLE WERE DISCOLORED AND APPEARED TO BE MELTED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE END OF A MAPPING PROCEDURE A HOLE WAS NOTED IN THE ENSITE ARRAY CATHETER. BEFORE BRINGING THE CATHETER TO LOW PROFILE FOR REMOVAL AT THE END OF THE PROCEDURE, THE PHYSICIAN VISUALIZED IT WITH FLUOROSCOPY AND NOTED THE CATHETER BALLOON APPEARED TO BE CONSIDERABLY DEFLATED. THE CATHETER WAS THEN BROUGHT TO LOW PROFILE IT WAS NOTED THAT SALINE/CONTRAST SOLUTION EXPELLED FROM THE BALLOON INTO THE BODY AND BLOOD WAS DRAWN INTO THE SYRINGE. WHEN THE CATHETER WAS REMOVED FROM THE BODY THE BALLOON WAS REFILLED AND IT WAS NOTED THERE WAS A "JET OF FLUID" COMING FROM THE BALLOON. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE VELOCITY SYSTEM HIGH DENSITY ARRAY CATHETER MTD ST. JUDE MEDICAL, AF DIVISION EC1000 13601625

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR