BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATERPILLAR EMBOLIZATION SYSTEM

    MDR report key: 10763147 · Received October 30, 2020

    Report

    Report Number
    9616666-2020-00105
    Event Type
    Malfunction
    Date Received
    October 30, 2020
    Report Date
    October 30, 2020
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    KRD
    UDI-DI
    00801741155307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION AND THE INVESTIGATION IS CONFIRMED FOR PEELED MATERIAL AND INCONCLUSIVE FOR FAILURE TO ADVANCE ISSUE. THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. (PRO CODE: KRD).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CTP027015U ARTERIAL EMBOLIZATION DEVICE ALLEGEDLY EXPERIENCED PEELED/DELAMINATED MATERIAL AND FAILURE TO ADVANCE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231634 CATERPILLAR EMBOLIZATION SYSTEM ARTERIAL EMBOLIZATION DEVICE KRD CLEARSTREAM TECHNOLOGIES LTD. CTP027015U CMEN0288 00801741155307

    Patients

    Seq Age Sex Outcome Treatment
    1