BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 4130196 · Received September 30, 2014

    Report

    Report Number
    2029214-2014-00556
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    IRVINE
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER WAS RETURNED FOR EVALUATION WITHOUT THE GUIDEWIRE. THE CATHETER WAS FLUSHED WITH WATER AND A MATERIAL WAS FOUND TO BE BLOCKING THE CATHETER LUMEN CAUSING THE BALLOON TO INFLATE. THE MATERIAL WAS TAKEN OUT AND ANALYZED AND FOUND TO BE CONSISTENT WITH COTTON. AFTER REMOVAL OF THE MATERIAL, THE BALLOON WAS TESTED WITH AN IN-HOUSE GUIDEWIRE AND IT PERFORMED AS INTENDED. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS CURRENTLY IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A CEREBRAL ANEURYSM. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PREPARATION OF THE HYPERFORM BALLOON, IT WAS REPORTED THE BALLOON COULD NOT BE DEFLATED AFTER IT WAS INFLATED. THE BALLOON WAS DEFLATED BY PULLING OUT THE GUIDEWIRE. THE DEVICE WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608403 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN IRVINE 104-4470 9801526

    Patients

    Seq Age Sex Outcome Treatment
    1