BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACLUDE AORTIC OCCLUSION DEVICE

    MDR report key: 3122997 · Received May 21, 2013

    Report

    Report Number
    3008500478-2013-00432
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K113182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND TEAR WAS FOUND ON THE BALLOON. AN ATTEMPT WAS MADE TO INJECT THE WATER INTO THE CARDIOPLEGIA PRESSURE LUMEN AND ROOT PRESSURE LUMEN. THE WATER WAS UNABLE TO FLOW THROUGH THE ROOT PRESSURE LUMEN DUE TO A HEAVY DRIED BLOOD INSIDE THE LUMEN. THE WATER WAS ABLE TO FLOWED THROUGH THE CARDIOPLEGIA LUMEN WITHOUT ANY DIFFICULTY. THE DEVICE IS UNDER FURTHER INVESTIGATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND TEAR WAS FOUND ON THE BALLOON. A RADIAL REAR WAS OBSERVED MIDWAY ALONG THE BALLOON. THE EDGES OF THE TEAR WERE JAGGED, BUT OF CONSISTENT THICKNESS, INDICATING A SHARP OBJECT HIT THE BALLOON WHEN IT WAS INFLATED. IF THE BALLOON HAD BURST DUE TO OVER-INFLATION, THE EDGES OF THE TEAR WOULD SHOW THINNED OUT AREAS DUE TO STRETCHING OF THE BALLOON BEFORE BURST. IN THE COMPLAINT DESCRIPTION, THE SALES REP INDICATED THAT ¿THE BALLOON LEAKED FROM A NEEDLE HOLE¿. THIS IS THE MOST LIKELY CAUSE OF THE BALLOON BURST DURING USE. THE SALES REP IS GOING TO FALLOW UP WITH THE CUSTOMER VIA A LETTER INDICATING THE LIKELY CAUSE OF THE BALLOON BURST. NO ADDITIONAL CORRECTIVE ACTIONS ARE BEING TAKEN AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE INTRACLUDE AORTIC OCCLUSION DEVICE, ICF100 BALLOON SPONTANEOUSLY DEFLATED DURING A CASE. THE CASE WAS A MITRAL/TRICUSPID REPAIR THROUGH A RIGHT THORACOTOMY. THE CASE WAS FINISHED BY FIBRILLATING THE HEART. NO ADDITIONAL DEVICES WERE USED. NO STATED PATIENT INJURY. THE LEAK WAS NOT NOTED DURING PREP. BALLOON WAS INFLATED AND IN USE FOR 60 MINUTES BEFORE IT POPPED. THE SALES REP BELIEVES "THE BALLOON LEAKED FROM A NEEDLE HOLE". THE TOTAL INFLATION VOLUME OF THE BALLOON WAS 35CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224483 INTRACLUDE AORTIC OCCLUSION DEVICE CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100

    Patients

    Seq Age Sex Outcome Treatment
    1