BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 3905057 · Received June 10, 2014

    Report

    Report Number
    1319211-2014-00080
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K914199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(4) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ANGIOGRAPHIC PROCEDURE. DURING PREP FOR THE PROCEDURE, WHEN OPENING THE STERILE PACKAGING, IT WAS NOTED THE TIP OF THE CATHETER WAS FRACTURED OF THE CATHETER SHEATH INSIDE OF THE PACKAGE. THE DEVICE WAS SET ASIDE, AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343195 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC. 592267

    Patients

    Seq Age Sex Outcome Treatment
    1