BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 3961157 · Received May 28, 2014

    Report

    Report Number
    2020394-2014-00242
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING-RELATED CAUSE FOR THIS EVENT. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER FOR THIS FAILURE MODE. THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVAL. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFO. IT IS UNK WHETHER PT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PTA BALLOON WOULD NOT DEFLATE AFTER AN INFLATION IN A FISTULA. A MICROPUNCTURE NEEDLE WAS INSERTED THROUGH THE SKIN TO DEFLATE THE BALLOON AND THE CATHETER WAS RETRACTED WITHOUT INCIDENT. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314932 CONQUEST PTA BALLOON DILATATION CATHETER Catheter, percutaneous DQY BARD PERIPHERAL VASCULAR, INC. REXB1957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention