BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATION CATHETER

    MDR report key: 3933767 · Received April 3, 2014

    Report

    Report Number
    2020394-2014-00153
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER FOR THIS FAILURE MODE. THE SAMPLE WAS NOT RETURNED; HOWEVER, TWO IMAGES WERE RETURNED. BASED ON THE IMAGES PROVIDED, FAILURE OF THE BALLOON TO DEFLATE CANNOT BE CONFIRMED. BASED UPON THE AVAILABLE INFORMATION , THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. IT IS UNKNOWN IF PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT DEFLATE AFTER ONE INFLATION IN THE SFA. A NEEDLE WAS INSERTED THROUGH THE SKIN TO DEFLATE THE BALLOON AND THE CATHETER WAS RETRACTED THROUGH THE INTRODUCER SHEATH WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200551 VASCUTRAK 2 PTA BALLOON DILATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFXC2579

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR