BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH INF.038 F4 100 JR-4

    MDR report key: 3003985 · Received December 9, 2008

    Report

    Report Number
    9616099-2008-02710
    Event Type
    Injury
    Date Received
    December 9, 2008
    Report Date
    November 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE PROCEDURE ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT IN ADDITION, THE DEVICE IS AVAILABLE FOR TESTING AND EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN PUT THE CATHETER IN, IT WAS TORQUED AND BROKE OFF IN THE PATIENT. THE BREAK WAS 15-20 CM FROM THE HUB AND THE PHYSICIAN WAS ABLE TO RETRIEVE IT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH INF.038 F4 100 JR-4 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 13369070

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention