BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO BALLOON CATHETER 64CM

    MDR report key: 801407 · Received December 19, 2006

    Report

    Report Number
    9612007-2006-00052
    Event Type
    Malfunction
    Date Received
    December 19, 2006
    Report Date
    December 18, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANT S.A.
    Product Code
    GWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS REPORTED BY THE GENERAL HOSPITAL OF VIENNA: BEFORE USING THE NEURO BALLOON CATHETER CAT# 7CB-D10 WITH THE PATIENT, THEY TESTED IT IN THE OR. THE FIRST ONE BURST WITH 0.7ML OF AIR PRESSURE AND THE SECOND ONE WITH 0.9ML OF AIR. THE BALLOON SHOULD NORMALLY INFLATE WITH 1 ML OF AIR PRESSURE. BOTH CATHETERS HAD LOT. NO. 0138918. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURO BALLOON CATHETER 64CM * GWG INTEGRA NEUROSCIENCES IMPLANT S.A. * 0138918

    Patients

    Seq Age Sex Outcome Treatment
    1 *