BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE MODEL UNKNOWN

    MDR report key: 4714175 · Received April 21, 2015

    Report

    Report Number
    2029214-2015-00407
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    April 12, 2008
    Report Date
    March 25, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/18408923.THIS REPORT WAS CREATED TO CAPTURE THE EVENTS RELATED TO THE UNKNOWN GUIDEWIRE. THE GUIDEWIRE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    CITATION: VASILIOS KATSARIDIS ET AL. CURATIVE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WITH ONYX IN 101 PATIENTS. NEURORADIOLOGY (2008) 50:589¿597. DOI 10.1007/S00234-008-0382-X. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC THROUGH LITERATURE REVIEW: PATIENTS WHO WERE TREATED WITH ONYX EMBOLIZATION FOR A BRAIN ARTERIOVENOUS MALFORMATIONS (AVM) FROM 1 JANUARY 2004 TO 31 DECEMBER 2007 (4 YEARS). 101 PATIENTS WERE IDENTIFIED (43 WOMEN, 58 MEN; MEAN AGE 38.8 YEARS; AGE RANGE (14-65). ONE PATIENT (1/101, 0.5%) HAD A SEVERE INTRA-PARENCHYMAL HEMORRHAGE IN THE OCCIPITAL LOBE DUE TO THE PERFORATION OF A FEEDING ARTERY BY THE GUIDE-WIRE AND WAS TREATED BY SURGICAL REMOVAL OF BOTH THE HEMATOMA AND THE MALFORMATION; THIS PATIENT SUBSEQUENTLY HAD AN EXCELLENT RECOVERY. PROCEDURE WAS PERFORMED WITH A COMBINATION OF THE FLOW-GUIDED AND THE WIRE-GUIDED TECHNIQUES USING 0.010 INCH OR A 0.008 INCH WIRE (SILVERSPEED OR MIRAGE). IT IS UNKNOWN WHICH WAS USED IN THIS EVENT. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR#S: 2029214-2015-00362, 2029214-2015-00363, 2029214-2015-00402, 2029214-2015-00408.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264674 GUIDEWIRE MODEL UNKNOWN GUIDEWIRE, CATHETER DQX COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R