BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH TEMPO COBRA II 65CM 2SHC

    MDR report key: 476328 · Received August 7, 2003

    Report

    Report Number
    9616099-2003-00054
    Event Type
    Injury
    Date Received
    August 7, 2003
    Date of Event
    July 9, 2003
    Report Date
    August 7, 2003
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISTAL PORTION OF THE CATHETER (20CMS) BECAME DETACHED DURING ANTEGRADE STENT INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO COBRA II 65CM 2SHC DIAGNOSTIC ENDOVASCULAR CATHETERS DQO CORDIS DE MEXICO NA 40103757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN