BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1030572 · Received April 14, 2008

    Report

    Report Number
    9616099-2008-00990
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K982770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVAL; HOWEVER, AS OF TO DATE, IT HAS NOT BEEN RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CARDIOVASCULAR PROCEDURE, THE GUIDE CATHETER KINKED AND BROKE INSIDE THE PT. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK