BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA, INC SEPARATOR 8

    MDR report key: 8604591 · Received May 10, 2019

    Report

    Report Number
    MW5086567
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    May 5, 2019
    Report Date
    May 8, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INDIGO SYSTEM, SEPARATOR 8 WAS USED DURING AN EMERGENCY PULMONARY THROMBECTOMY. DURING THE PROCEDURE, WIRE TIP BROKE OFF AND BECAME DISLODGED IN THE PULMONARY ARTERY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391802 PENUMBRA, INC SEPARATOR 8 CATHETER, EMBOLECTOMY DXE PENUMBRA, INC. SEPARATOR 8 F87602

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability