BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2445008 · Received February 9, 2012

    Report

    Report Number
    2029214-2012-00046
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER HAS BEEN EVALUATED AND A LARGE AMOUNT OF BLOOD WAS FOUND IN THE BALLOON LUMEN. BASED UPON THE FINDINGS, THE LARGE AMOUNT OF BLOOD FOUND IN THE BALLOON ASSEMBLY WAS THE LIKELY CAUSE OF THE NON-DEFLATION. THE INSTRUCTION FOR USE WARNS "INADVERTENT PROXIMAL GUIDEWIRE MOVEMENT CAN CAUSE BLOOD TO ENTER THE BALLOON LUMEN WHICH MAY INHIBIT BALLOON DEFLATION."(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON COULD NOT BE VISUALIZED DURING CONTRAST INJECTION (50:50 RATIO). THE PHYSICIAN DECIDED TO USED 90% CONCENTRATION CONTRAST MEDIA TO INFLATE THE BALLOON AND IT COULD NOT BE DEFLATED. THE INFLATED BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERGLIDE OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4112 8119140

    Patients

    Seq Age Sex Outcome Treatment
    1