BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1112728 · Received August 11, 2008

    Report

    Report Number
    2020394-2008-00218
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS RECEIVED FOR EVAL. THE REFOLDING TOOL, THE BALLOON GUARD, AND THE SHEATH WERE NOT RETURNED WITH THE SAMPLE. THE BIFURCATE AND THE SHAFT OF THE CATHETER APPEARED INTACT. THERE APPEARED TO BE NO KINKS ON THE CATHETER AND NO BLOOD ON THE HUBS. A GUIDE WIRE (0.035INCH) WAS USED TO CHECK THE PATENCY AND THE CATHETER WAS PATENT, BUT IT WAS DIFFICULT TO PASS THROUGH THE BALLOON LUMEN. THERE WAS A BREAK IN THE SHAFT OF THE CATHETER APPROX 6.1CM FROM THE TIP OF THE BALLOON. THE BREAK WAS CIRCUMFERENTIAL AND WAS LOCATED IN THE AREA WHERE THE GUIDE WIRE HAD DIFFICULTY GOING THROUGH. THE BALLOON WAS INFLATED WITH AIR USING AN INFLATION DEVICE UP TO 30ATM. BUBBLES CAME OUT OF THE CIRCUMFERENTIAL BREAK AND THE BALLOON COULD NOT BE INFLATED DUE TO THIS. THE BREAK APPEARED CLEAN AND APPEARED TO BE AT THE PROXIMAL BOND OF THE BALLOON. THE SMALL AREA WHERE THE SHAFT IS STILL WHOLE, SHOWS EVIDENCE OF STRETCHING ON THE INSIDE DIAMETER OF THE SHAFT. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR A SHAFT BREAK, THE ROOT CAUSE IS UNK. IT IS UNK IF PT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT. THE CURRENT IFU (INSTRUCTION FOR USE STATES; WARNING: DO NOT EXCEED THE RBP RECOMMENDED FOR THIS DEVICE. BALLOON RUPTURE MAY OCCUR IF THE RBP RATING IS EXCEEDED. TO PREVENT OVER PRESSURIZATION, USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY A CONQUEST PTA BALLOON HAD A PINHOLE RUPTURE. THIS WAS FOUND UPON THE INITIAL INFLATION, WHEN CONTRAST APPEARED TO BE LEAKING, AND THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS ON A LEFT FOREARM FISTULA, USING A 6 F SHEATH AND 0.035 GLIDEWIRE. THE PHYSICIAN REMOVED THE DEVICE, AND USED ANOTHER PTA BALLOON CATHETER SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFSC1011

    Patients

    Seq Age Sex Outcome Treatment
    1