BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE

    MDR report key: 6443203 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00256
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    January 3, 2008
    Report Date
    March 2, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MJN
    PMA / PMN Number
    K021066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS HAVE BEEN MADE TO OBTAIN SPECIFIC DEVICE INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THEREFORE, THIS EVENT COULD NOT BE CONFIRMED, AS THE CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    CITATION: LOW-PRESSURE BALLOON ANGIOPLASTY WITH ADJUVANT PHARMACOLOGICAL THERAPY IN PATIENTS WITH ACUTE ISCHEMIC STROKE CAUSED BY INTRACRANIAL ARTERIAL OCCLUSIONS. NOGUEIRA RG1, SCHWAMM LH, BUONANNO FS, KOROSHETZ WJ, YOO AJ, RABINOV JD, PRYOR JC, HIRSCH JA. NEURORADIOLOGY. 2008 APR;50(4):331-40. DOI: 10.1007/S00234-007-0340-Z. EPUB 2008 JAN 3. MEDTRONIC RECEIVED REPORT THAT DURING THE USED OF THE BALLOON GUIDE CATHETER, THE DEVICE WAS REPORTED TO HAVE INCOMPLETE BALLOON DEFLATION, HOWEVER, THIS EVENT HAD NO ANY CLINICAL OR RADIOGRAPHIC CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225936 HYPERGLIDE CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1