BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 1080764 · Received July 22, 2008

    Report

    Report Number
    9610978-2008-00189
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPTA PRO BALLOON CATHETER IS AVAILABLE FOR EVAL AND TESTING. HOWEVER, THIS DEVICE HAS NOT BEEN RECEIVED AS OF TO DATE. ADDITIONAL INFO HAS BEEN REQUESTED, AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON RUPTURED AND THE TIP SEPARATED. INTERVENTION PREVENT PERMANENT IMPAIRMENT/DAMAGE IS REQUIRED AND HAS BEEN PLANNED. HOWEVER, THE METHOD TO REMOVE THE TIP IS UNKNOWN AT THIS TIME. THE PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETER (LIT) LIT CORDIS EUROPA, N.V. NA R1107170

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention