BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 1060158 · Received June 11, 2008

    Report

    Report Number
    2029214-2008-00107
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER AND GUIDEWIRE WERE RETURNED FOR EVALUATION. THE GUIDEWIRE WAS FOUND BROKEN IN TWO SEGMENTS WITH THE DISTAL SEGMENT FOUND LODGED IN THE BALLOON SUB-ASSEMBLY. THE BALLOON WAS SUCCESSFULLY TESTED FOR INFLATION/DEFLATION WITH THE DISTAL SEGMENT OF THE GUIDEWIRE INSIDE THE BALLOON. THERE WAS BLOOD FOUND IN THE BALLOON LUMEN. BASED ON THE INVESTIGATION, THERE WAS NO DEFECT FOUND WITH THE BALLOON CATHETER. THE GUIDEWIRE LIKELY BROKE DURING MANIPULATION AS THE PROXIMAL SEGMENT SHOWED EVIDENCE OF THE GUIDEWIRE UNDER EXTERNAL FORCE.

    Description of Event or Problem · 1

    DURING PROCEDURE, AFTER HAVING EMBOLIZED THE BASILAR TIP ANEURYSM, IT WAS REPORTED THE BALLOON COULD NOT BE DEFLATED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE GUIDEWIRE, BUT IT WAS STUCK INSIDE THE BALLOON CATHETER. THE BALLOON SYSTEM WAS THEN REMOVED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER MJN EV3 NEUROVASCULAR 104-4470 5345602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK