BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 2924006 · Received December 14, 2012

    Report

    Report Number
    1319211-2012-00252
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K914199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER 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, (B)(6) 2012, A PATIENT OF UNKNOWN GENDER AND AGE PRESENTED FOR AN ANGIOGRAPHIC TREATMENT PROCEDURE TO REMOVE A FILTER. WHILE PERFORMING THE PROCEDURE, THE TREATING PHYSICIAN PULLED BACK ON THE CATHETER. AT THAT TIME, THE CATHETER STRETCHED AND FRACTURED WHILE THE GUIDEWIRE WAS STILL ADVANCED IN THE CATHETER. WHEN THIS WAS NOTICED BY THE TREATING PHYSICIAN, BOTH THE CATHETER AND THE GUIDEWIRE WERE REMOVED AS ONE UNIT. NO FRACTURED PIECES OF THE CATHETER WERE LEFT IN THE PATIENT. THE DEVICE WAS SET ASIDE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OF THE SAME DEVICE WITHOUT ANY REPORTED COMPLICATIONS. IT WAS REPORTED THE PATIENT WAS STABLE AT THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS 582744

    Patients

    Seq Age Sex Outcome Treatment
    1