BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILER BALLOON DILATATION CATHETER

    MDR report key: 3073076 · Received April 8, 2013

    Report

    Report Number
    1319211-2013-00047
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT 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 ON (B)(6) 2013 A (B)(6) FEMALE PATIENT PRESENTED FOR A THROMBECTOMY PROCEDURE OF THE LEFT ARM. DURING THE PROCEDURE, THE TREATING PHYSICIAN INFLATED THE PTA BALLOON TO 10 ATM AT WHICH TIME THE BALLOON BURST. THE DEVICE WAS REMOVED FROM THE PATIENT AND SET ASIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OF THE SAME DEVICE. IT IS REPORTED THE PATIENT IS DOING FINE AND HAS SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE REPORTED FAILED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144434 PROFILER BALLOON DILATATION CATHETER BALLOON DILATATION CATHETER DQY ANGIODYNAMICS 585847

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR