BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERGLIDE

    MDR report key: 6443210 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00257
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED ANALYSIS. ATTEMPTS TO OBTAIN SPECIFIC DETAILS HAVE BEEN MADE. HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE THAT THE DEVICE WAS DEFECTIVE OR MALFUNCTIONED. THE REPORTED EVENTS ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). MDR RELATED TO THIS EVENT: 2029214-2017-00256.

    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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A BALLOON AN EMBOLIC EVENT OCCURRED TO THE DISTAL POSTERIOR INFERIOR CEREBELLAR ARTERY RESULTING IN A STROKE, DURING PTA FOR VERTEBROBASILAR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225942 HYPERGLIDE CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other