BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 638429 · Received August 25, 2005

    Report

    Report Number
    3003742446-2005-01679
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Report Date
    August 25, 2005
    Manufacturer
    CORIDS LLC(PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PROXIMAL HUB OF THE PRODUCT CAME OFF THE SHAFT. THERE WAS NO INJURY TO PT. THE PRODUCT WAS CLINICALLY USED BUT IS NOT AVAILABLE TO BE RETURNED. ADDITIONAL DETAILS OF THE EVENT ARE NOT AVAILABLE. THIS PRODUCT IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORIDS LLC(PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN