BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 2436973 · Received February 2, 2012

    Report

    Report Number
    3008500478-2012-00194
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 10, 2012
    Report Date
    February 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PRIOR TO INFLATING THE BALLOON, THE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION. IT IS NOTED THAT DURING VISUAL INSPECTION OF THE BALLOON SURFACE, THERE ARE TWO LONG SCRATCHES ON THE BALLOON ON OPPOSING SIDES. WATER WAS INTRODUCED INTO THE BALLOON LUMEN AND THERE ARE TWO PINHOLE LEAKS THAT ARE COMING OUT OF ONE OF THE SCRATCHES ON THE BALLOON. WATER WAS INTRODUCED INTO THE INFUSION AND PRESSURE LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. VISUALLY, THERE ARE NO OTHER DEFECTS DETECTED. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT NUMBER 883013, THERE WERE NO NONCONFORMITIES OBSERVED WITH THE MANUFACTURING OF THIS LOT. WE CANNOT DETERMINE ROOT CAUSE OF THE FAILURE MODE. THE DEVICE BALLOON LEAKS IN THE AREA ON THE BALLOON THAT HAS A SCRATCH. THIS ISSUE COULD NOT BE TRACED TO A MANUFACTURING ERROR PRODUCT DESIGN ISSUE; HENCE A PRA WILL NOT BE INITIATED. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING PREP THE ENDOCLAMP 1001 BALLOON LOOKED FINE AND WAS HOLDING VOLUME. IT WAS PLACED IN THE USUAL FASHION WITHOUT ANY ISSUE. THE MD ADDED VOLUME TO THE BALLOON AND SAW THE BALLOON PRESSURE RISE AND HEMODYNAMICS LOOKED NORMAL. THEN AS HE WAS LOOKING AT THE ECHO, THERE WAS NO SIGHT OF THE BALLOON AND NO OCCLUSION. THE BALLOON WOULD NOT HOLD PRESSURE AND WHEN HE REMOVED IT HE SAW TWO PINHOLES IN THE BALLOON. THE MD SWITCHED OUT THE BALLOON FOR ANOTHER ONE WHICH WORKED FINE. THERE WAS A PROLONGED OR TIME OF 10 MINUTE BUT NO ADVERSE PATIENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER AORTIC CATHETER DXC EDWARDS LIFESCIENCES EC1001 883013

    Patients

    Seq Age Sex Outcome Treatment
    1