BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC

    MDR report key: 6458029 · Received April 4, 2017

    Report

    Report Number
    2029214-2017-00367
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    February 27, 2006
    Report Date
    March 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BRAIN AVM EMBOLIZATION WITH ONYX. W.J.VAN ROOIJ, M. SLUZEWSKI, G. N. BEUTE ET. AL. THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS RELATED TO THIS ARTICLE: 2029214-2017-00359 2029214-2017-00360 2029214-2017-00361 2029214-2017-00362 2029214-2017-00363 2029214-2017-00364 2029214-2017-00365 2029214-2017-00366 2029214-2017-00367 2029214-2017-00368.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT DURING EMBOLIZATION PROCEDURE WITH ONYX, THE CATHETER GLUED IN THE ANTERIOR VENOUS MALFORMATION (AVM) IN 2 PATIENTS. MICROCATHETER WAS CUT OFF IN THE GROIN WITHOUT CLINICAL SEQUELAE. BETWEEN MAY 2000 AND DECEMBER 2005, 44 PATIENT WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THERE WERE 18 WOMEN AND 26 MEN WITH A MEAN AGE OF 42.4 YEARS (MEDIAN 44, RANGE 14-71 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240182 ULTRAFLOW HPC CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) UNK NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1