BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM

    MDR report key: 3253764 · Received July 18, 2013

    Report

    Report Number
    3253764
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 18, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OCCLUSION BALLOONS WOULD NOT STAY INFLATED IN THE PATIENT. TWO BALLOONS WERE TRIED, BOTH HAD SAME PROBLEM: ONCE INFLATED, THEY ARE OBSERVED UNDER FLUOROSCOPY, THEN SOME CONTRAST IS INJECTED. THEN VIEWED UNDER FLUOROSCOPY AGAIN AND IF THE CONTRAST HAS GOTTEN PAST THE AREA THAT SHOULD BE OCCLUDED, THEY DETERMINE THAT THE BALLOON IS NOT STAYING INFLATED. A DIFFERENT BRAND BALLOON WAS SUCCESSFULLY USED AFTER THE TWO BALLOONS FAILED, AND THE PATIENT WAS NOT HARMED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?USE OF OCCLUSION BALLOON IN DIAGNOSTIC CERVICAL-CEREBRAL ANGIOGRAM TO INCLUDE BALLOON TEST OCCLUSION AND POSSIBLE TUMOR EMBOLIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335227 HYPERFORM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EV3 NEUROVASCULAR * 9686826
    335228 HYPERFORM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EV3 NEUROVASCULAR * 9718321

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR