BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLENT PROXI THROMBECTOMY SET

    MDR report key: 4151518 · Received October 6, 2014

    Report

    Report Number
    2183460-2014-00017
    Event Type
    Death
    Date Received
    October 6, 2014
    Date of Event
    March 28, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ELECTRICAL SAFETY CHECK OF THE ANGIOJET ULTRA CONSOLE WAS PERFORMED ON (B)(4) 2014. THE CONSOLE PASSED THE SAFETY CHECK. THE ANGIOJET SOLENT PROXI CATHETER THAT WAS IN USE DURING THE EVENT WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. BASED ON THE LIMITED INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED ISSUE. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    A BAYER MEDICAL CARE REPRESENTATIVE REPORTED THAT A PATIENT DEATH HAD OCCURRED TWO HOURS AFTER SUCCESSFUL THROMBECTOMY TREATMENT WAS PERFORMED USING AN ANGIOJET SOLENT PROXI CATHETER AND ULTRA CONSOLE. NOTE: THIS EVENT OCCURRED IN (B)(6) ON (B)(6) 2014; HOWEVER, WE WERE NOT MADE AWARE OF THIS EVENT UNTIL (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623923 SOLENT PROXI THROMBECTOMY SET THROMBECTOMY CATHETER DXE BAYER INTERVENTIONAL 109676-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death