BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILER BALLOON DILATATION CATHETER

    MDR report key: 2823694 · Received October 10, 2012

    Report

    Report Number
    1319211-2012-00220
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ANGIOPLASTY PROCEDURE. AFTER MULTIPLE SUCCESSFUL INFLATIONS, AT THE COMPLETION OF THE PROCEDURE, THE TREATING PHYSICIAN WENT TO REMOVE THE PROFILER BALLOON FROM THE PATIENT VIA A 6F SHEATH. THE PHYSICIAN REMOVED THE BALLOON AND SHEATH TOGETHER WITHOUT FURTHER COMPLICATIONS. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS PRODUCT PROBLEM. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER DQY ANGIODYNAMICS 569644

    Patients

    Seq Age Sex Outcome Treatment
    1