BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1941191 · Received December 9, 2010

    Report

    Report Number
    2020394-2010-00362
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFUF1715. THE DEVICE HAS BEEN RETURNED AND THE EVAL IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED ON THE FIRST INFLATION WHILE BEING USED IN THE CEPHALIC OUTFLOW AREA. REPORTEDLY, THE BALLOON WAS NOT INFLATED NEAR RBP. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. THE PTA BALLOON DILATATION CATHETER WAS REMOVED IN ITS ENTIRETY FROM THE PT WITHOUT INCIDENT. 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. GFUF1715

    Patients

    Seq Age Sex Outcome Treatment
    1