BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    MDR report key: 2380736 · Received November 1, 2011

    Report

    Report Number
    2029214-2011-00360
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    September 20, 2011
    Report Date
    October 11, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER HAS BEEN EVALUATED AND CONFIRMED THE CATHETER RUPTURED AT APPROXIMATELY 9.7 CM FROM THE DISTAL TIP OF THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER RUPTURED PROXIMALLY TO THE BALLOON DURING PROCEDURE. PRIOR TO USE, THE BALLOON WAS PREP AND CONFIRMED WORK AS INTENDED. 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 9391000

    Patients

    Seq Age Sex Outcome Treatment
    1