BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1012849 · Received March 12, 2008

    Report

    Report Number
    2020394-2008-00050
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION TO DATE. BASED ON THE INFORMATION RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS WORKING ON A CONTRALATERAL ILIAC STENOSIS. HE WAS USING A 180 SUPERSTIFF 0.035" GUIDE AND A 6F SHEATH. THE BALLOONING WAS SUCCESSFUL. WHILE TRYING TO WITHDRAW THE BALLOON, IT JAMMED IN THE SHEATH. THE DOCTOR DID HAVE NEGATIVE PRESSURE ON THE BALLOON USING AN INFLATION DEVICE AND THERE WERE NO SIGNS OF CONTRAST REMAINING IN THE BALLOON. THE GUIDE WIRE WAS LEFT IN THE PLACE AND THE BALLOON AND SHEATH WERE REMOVED AS A UNIT. THE PROCEDURE WAS FINISHED WITH ANOTHER PTA BALLOON AND A NEW SHEATH WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY REPORTED.

    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