BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 1111740 · Received August 13, 2008

    Report

    Report Number
    2029214-2008-00139
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER AND GUIDEWIRE WERE RETURNED FOR EVALUATION. THE BALLOON WAS TESTED FOR INFLATION/DEFLATION AND PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON WAS USED TO ASSIST IN AN ANEURYSM COILING TREATMENT PROCEDURE. DURING FIRST INFLATION, THE BALLOON WORKED AS INTENDED. DURING SECOND INFLATION, THE BALLOON STARTED TO DEFLATE NEAR THE PROXIMAL MARKER AND THE SAME OCCURRED WITH THE THIRD AND FOURTH INFLATION. DUE TO THE BALLOON NOT MAINTAINED INFLATING WHILE DEPLOYING COILS, ONE OF THE COIL LOOP WAS OBSERVED PROTRUDING INTO THE PARENT ARTERY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4127 4010495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention