BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2770742 · Received October 3, 2012

    Report

    Report Number
    2029214-2012-00507
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    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 WITH THE GUIDEWIRE 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. WHEN BLOOD ENTERS THE BALLOON LUMEN, THIS MAY INHIBIT BALLOON DEFLATION. (B)(4).

    Description of Event or Problem · 1

    DURING PROCEDURE, IT WAS REPORTED THE BALLOON COULD NOT BE DEFLATED. THE INFLATED BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT, THE BALLOON WAS FOUND RUPTURED WHICH LIKELY OCCURRED DURING REMOVAL. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON SYSTEM MJN EV3 NEUROVASCULAR 104-4470 9560162

    Patients

    Seq Age Sex Outcome Treatment
    1