BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 3170808 · Received May 23, 2013

    Report

    Report Number
    1319211-2013-00072
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K914199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MFR FOR A DEVICE EVAL. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. AS REPORTED, THERE WAS NO PT HARM OR INJURY AS THE PRODUCT DID NOT COME INTO CONTACT WITH THE PT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013, A PT OF UNK AGE AND GENDER PRESENTED FOR AN UNK PROCEDURE. DURING PREPARATION FOR THE PROCEDURE IT WAS NOTED THE TIP OF CATHETER HAD FRACTURED. THE DEFECTIVE CATHETER WAS PUT ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE CUSTOMER DUE TO THIS EVENT AS THE DEFECTIVE PRODUCT NEVER CAME INTO CONTACT WITH THE PT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228852 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS 570154

    Patients

    Seq Age Sex Outcome Treatment
    1