BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATH.

    MDR report key: 1213203 · Received October 22, 2008

    Report

    Report Number
    2020394-2008-00295
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MANUFACTURING LOT NUMBER. THE DEVICE HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING A PTA BALLOON TO DILATE A STENOSIS IN THE FEMORAL ARTERY. HE USED A CROSS OVER SHEATH AND A STANDARD GUIDEWIRE. IT IS ALLEGED THAT THE PTA CATHETER SHAFT KINKED IN THE STEEP BIFURCATION, TOGETHER WITH THE WIRE. THE PHYSICIAN TRIED TO REPLACED THE WIRE WITH A SOFTER WIRE, HOWEVER, IT COULD NOT PASS THE BIFURCATION WITH THE KINKED PTA CATHETER. THIS COULD ONLY BE DONE WITH AN ULTRA-THIN CORONARY WIRE. REPORTEDLY THE PTA WAS THEN COMPLETED SUCCESSFULLY. DURING REMOVAL OF THE PTA BALLOON CATHETER THE SHAFT GOT STUCK BECAUSE OF THE KINK AND TORE OFF IN THE AREA OF THE KINK. IT WAS POSSIBLE TO REMOVE THE COMPLETE PTA DEVICE TOGETHER WITH WIRE AND SHEATH, SO THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATH. LIT BARD PERIPHERAL VASCULAR, INC. 93CS0005

    Patients

    Seq Age Sex Outcome Treatment
    1