BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILER BALLOON DILATATION CATHETER

    MDR report key: 2000040 · Received February 18, 2011

    Report

    Report Number
    1319211-2011-00019
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MFR AND AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2011, WHILE PERFORMING AN ANGIOGRAPHIC PROCEDURE, A PTA BALLOON BURST AT APPROX 12 ATMS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PT WITHOUT INCIDENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NO HARM TO THE PT DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER DQY ANGIODYNAMICS NA 522439

    Patients

    Seq Age Sex Outcome Treatment
    1