BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET AVX THROMBECTOMY CATHETER

    MDR report key: 2642928 · Received June 26, 2012

    Report

    Report Number
    2183460-2012-00011
    Event Type
    Death
    Date Received
    June 26, 2012
    Date of Event
    April 25, 2012
    Report Date
    June 26, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF PT DEATH DURING AN ANGIOJET PROCEDURE. THE PT IS A (B)(6) FEMALE OF UNK MEDICAL HISTORY, BUT HAS AN ARTRIAL/VENOUS (AV) FISTULA GRAFT. ON (B)(6) 2012, THE PHYSICIAN WAS PERFORMING A DECLOT PROCEDURE WITH AN ANGIOJET DEVICE (MODEL UNK) WHEN THE PT COMPLAINED OF SHORTNESS OF BREATH. THE PHYSICIAN STOPPED USING THE ANGIOJET DEVICE AND THEN THE PT CODED. THE PT WAS INTUBATED AND THAN A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH SHOWED MULTIPLE PULMONARY EMBOLISMS (PES). THE PT WAS BROUGHT BACK TO THE CATH LAB ON (B)(6) 2012 FOR ADD'L AV FISTULA DECLOT. THE PT WAS STILL INTUBATED SINCE THE FIRST PROCEDURE. THE PHYSICIAN AGAIN PERFORMED A DECLOT PROCEDURE WITH AN ANGIOJET AVX THROMBECTOMY SET. THE PT AGAIN CODED AND THEN PASSED AWAY DURING THIS PROCEDURE. THE PHYSICIAN WAS NOT SURE IF THE PES WERE RELATED TO THE ANGIOJET DEVICE. THE IFU WARNS THE USER. "OPERATION OF THE CATHETER MAY CAUSE EMBOLIZATION OF SOME THROMBUS AND/OR THROMBOTIC PARTICULAR DEBRIS. DEBRIS EMBOLIZATION MAY CAUSE DISTAL VESSEL OCCLUSION, WHICH MAY FURTHER RESULT IN HYPOPERFUSION OR TISSUE NECROSIS." THIS EVENT IS CONSIDERED REPORTABLE AS THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND THE NOTED EVENTS WHICH INCLUDE THE PE EPISODES AND THE NOTED PT'S DEATH CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    PHYSICIAN WAS DOING AV FISTULA WORK WHEN PT COMPLAINED OF SHORTNESS OF BREATH. DR. STOPPED ANGIOJETTING AND THEN THE PT CODED. SHE WAS INTUBATED AND THEN CT SHOWED MULTIPLE PES. TWO TO THREE WEEKS LATER, SHE WAS BROUGHT BACK FOR MORE AV FISTULA WORK, STILL INTUBATED, CODED AGAIN AND THEN PASSED AWAY. PHYSICIAN IS NOT SURE THAT THE PES ARE RELATED TO ANGIOJET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX THROMBECTOMY CATHETER THROMBECTOMY CATHETER DXE BAYER INTERVENTIONAL, INC 105039-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death