BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 2672579 · Received July 19, 2012

    Report

    Report Number
    1319211-2012-00132
    Event Type
    Malfunction
    Date Received
    July 19, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K914199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    F/U WITH THE USER NOTED THAT THIS DEVICE WAS BEING USED TO DELIVER A COOK MEDICAL TORNADO EMBOLIZATION COIL. THE INSTRUCTIONS FOR USE FOR THE ANGIODYNAMIC'S ANGIOGRAPHIC CATHETER STATES THAT "ANGIODYNAMICS ANGIOGRAPHIC CATHETER ARE FOR USE WHERE ANGIOGRAPHIC DIAGNOSIS IS INDICATED." A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS THE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVAL. THE CUSTOMER'S COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED DEFECT IS UNK. HOWEVER, BASED ON F/U INFO FROM THE USER THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS USER ERROR AS THE ANGIODYNAMICS ANGIOGRAPHIC CATHETER ARE INTENDED FOR DIAGNOSIS AND NOT INDICATED FOR THE DELIVERY OF TREATMENT DEVICES. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    A PT OF UNK AGE AND UNK GENDER, PRESENTED FOR AN UNSPECIFIED PROCEDURE. AS REPORTED BY THE TREATING PHYSICIAN, THE COOK MEDICAL TORNADO EMBOLIZATION COIL, BECAME STUCK IN THE TIP OF THE ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF HARM OR INJURY TO THE PT DUE TO THIS PRODUCT PROBLEM. THE ANGIOGRAPHIC CATHETER WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS 565578

    Patients

    Seq Age Sex Outcome Treatment
    1