BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN MICRO CATHETERS

    MDR report key: 4738038 · Received April 29, 2015

    Report

    Report Number
    2029214-2015-00438
    Event Type
    Death
    Date Received
    April 29, 2015
    Date of Event
    May 16, 2012
    Report Date
    March 31, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/22591733 THIS REPORT WAS CREATED TO CAPTURE THE DEATH RELATED TO THE UNKNOWN MICROCATHETER. THE UNKNOWN CATHETERS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSES COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00435 2029214-2015-00434 2029214-2015-00436 2029214-2015-00433 (B)(4).

    Description of Event or Problem · 1

    CITATION: ZHONG-SONG SHI, ET AL. FLOW CONTROL TECHNIQUES FOR ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAE WAS FIRST PUBLISHED IN J NEUROINTERVENT SURG ON (B)(6) 2012. THE FOLLOWING REPORT WAS RECEIVED THROUGH LITERATURE REVIEW: BOTH ONYX 34 AND ONYX 18 WERE USED. ONYX 18 WAS UTILIZED WHEN DISTAL MIGRATION WAS FELT TO BE LESS LIKELY. ONYX COMPATIBLE MARATHON OR ECHELON 10 MICROCATHETER WAS NAVIGATED TO A POSITION AS CLOSE TO THE FISTULA AS OBTAINED. FIFTY-EIGHT PATIENTS UNDERWENT A TOTAL OF 84 EMBOLIZATION SESSIONS, 55 ADULT PATIENTS AND THREE PEDIATRIC PATIENTS. THERE WERE 33 WOMEN AND 25 MEN RANGING FROM 12 WEEKS TO 88 YEARS OF AGE. NEAR COMPLETE (90-99%) OCCLUSION OCCURRED IN 18 PATIENTS AND PARTIAL OCCLUSION IN FIVE PATIENTS. A PATIENT PRESENTED WITH INTRACEREBRAL HEMORRHAGE HAD A COMPLICATION OF MICROCATHETER ENTRAPMENT IN THE ONYX CAST AND RETENTION. THE FAMILY WITHDREW CARE DUE TO POOR PROGNOSIS. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282745 UNKNOWN MICRO CATHETERS CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death