BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ THROMBECTOMY DEVICE

    MDR report key: 156095 · Received March 10, 1998

    Report

    Report Number
    2183870-1998-00015
    Event Type
    Malfunction
    Date Received
    March 10, 1998
    Date of Event
    January 20, 1998
    Report Date
    January 20, 1998
    Manufacturer
    MICROVENA CORP.
    Product Code
    DXE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MEDWATCH REPORT ERRONEOUSLY REPORTED THE LOT NUMBER FOR THE ATD 601 DEVICE INVOLVED IN THE INCIDENT HAS LOT # 974598. THE LOT NUMBER FOR THE ATD 601 DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A DEVICE WAS BROKEN AFTER USE ON A SUBCLAVIAN THROMBECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ THROMBECTOMY DEVICE PERCUTANEOUS MECHANICAL THROMBECTOMY CATHETER DXE MICROVENA CORP. ATD 601 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN