BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 3138108 · Received May 24, 2013

    Report

    Report Number
    3003793491-2013-00604
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE IVTM QUATTRO CATHETER IN COMPLAINT WAS RETURNED TO ZOLL ON 06/26/2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED TRACES OF DESICCATED BLOOD ALONG THE INNER BALLOON LINING AND SHAFT. PART OF THE OUTFLOW TUBING WAS KNOTTED AS IT WAS RECEIVED AT ZOLL. NO OTHER DISCREPANCIES WERE NOTED. FUNCTIONAL TESTING WAS PERFORMED DURING WHICH THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE THAT HAD BEEN SUBMERGED INTO WATER. AS SOON AS THE DEVICE WAS PRESSURIZED, BUBBLES APPEARED INDICATING A LEAK. THE LEAK WAS LOCATED AT THE PROXIMAL END OF THE MEDIAL BALLOON (ADJACENT TO THE BONDING AREA). AFTER THE BALLOON WAS REMOVED FROM THE WATER, THE MEDIAL BALLOON DISLODGED FROM PROXIMAL SIDE OF THE SHAFT. NO ADDITIONAL ISSUES WERE OBSERVED. BASED ON THE EVALUATION RESULTS, THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL BALLOON OF AN IVTM QUATTRO CATHETER DID NOT APPEAR TO BE INFLATED WHILE BEING INSERTED IN A FEMALE PT. PT FORMED A THROMBUS. IT WAS REPORTED THAT SHE PASSED AWAY AND THE CAUSE OF DEATH WAS DUE TO AN EMBOLISM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THE PRIMARY CAUSE FOR HOSPITALIZATION AND NEED FOR IVTM THERAPY WAS DUE TO SERIOUS BRAIN TRAUMA. PT EXPERIENCED SERIOUS BRACHYCARDIA AND DROP OF BLOOD PRESSURE. MEDICATION AND TEMPERATURE OF THE IVTM WAS RAISED FROM 34 TO 35 DEGREES C AND THE PARAMETERS GOT BETTER. BEFORE THAT, THEY USED SURFACE COOLING WHERE THEY DIDN'T EXPERIENCE BRACHYCARDIA. CATHETER INSERTION WAS SMOOTH WITH NO PROBLEMS. IT WAS KEPT IN FOR 2 DAYS. ANOTHER CENTRAL VENOUS CATHETER (CVC) WAS PLACED PRIOR TO QUATTRO CATHETER PLACEMENT. IT WAS REPORTED THAT THE PHYSICIAN USED THE QUATTRO CATHETER FOR THE FIRST TIME AND WAS NOT AWARE OF THE DIAMETER OF THE FIRST BALLOON BEING INTRODUCED IN THE ILIACA. HE MAY HAVE MADE AN ERROR IN SAYING THAT IT WAS NOT INFLATED. A LARGE THROMBUS WAS FOUND DURING USAGE, BUT THE PHYSICIAN SUSPECTED THAT IT WAS ALREADY THERE. THE THROMBUS WAS QUITE LONG, BUT WHERE THE CATHETER WAS SHOWN AS BEING LOCATED NEAR THE HEART, THE THROMBUS MADE A CURVE INTO THE VENA HEPATICA. THE TREATING PHYSICIAN DOES NOT BELIEVE THAT THE IVTM QUATTRO CATHETER WAS THE CAUSE OF DEATH, BUT DUE TO A COMBINATION OF MANY FACTORS, INCLUDING THE LATE DVT PROPHYLAXIS AND ANOTHER CVC. IN ADDITION, THE PT HAD A POOR LIFE EXPECTANCY DUE TO BRAIN TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230547 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-4593 38073

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| O DVT PROPHYLAXIS| SURFACE COOLING