BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1082774 · Received July 24, 2008

    Report

    Report Number
    2020394-2008-00199
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE CURRENT IFU (INFORMATION FOR USE) STATES: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PTA BALLOON WOULD NOT RETRACT THROUGH THE SHEATH. THE ENTIRE SYSTEM WAS REMOVED WITH THE SHEATH. THE PHYSICIAN HAD COMPLETED HIS PROCEDURE AND WAS REMOVING THE BALLOON WHEN THIS OCCURRED. NO PATIENT INJURY REPORTED. NO ADDITIONAL INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1