BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1903159 · Received November 11, 2010

    Report

    Report Number
    2020394-2010-00329
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 QC TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFUG0991. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT DEFLATE COMPLETELY AFTER BEING USED WITHIN STENTS IN THE CEPHALIC VEIN AND COULD NOT BE RETRACTED INTO THE INTRODUCER SHEATH; SUBSEQUENTLY, THE BALLOON CATHETER WAS REMOVED TOGETHER WITH THE SHEATH AS A SINGLE UNIT. ANOTHER SHEATH AND PTA BALLOON DILATATION CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF 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. GFUG0991

    Patients

    Seq Age Sex Outcome Treatment
    1