BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERFORM OCCLUSION BALLOON SYSTEM

    MDR report key: 2879609 · Received December 19, 2012

    Report

    Report Number
    2029214-2012-00748
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NUF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON HAS BEEN RETURNED AND EVALUATED. A LEAK WAS FOUND AT 1.3MM FROM THE DISTAL TIP.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A TARGET 360 SOFT 5X10 (FROM STRYKER) FIRST AND THEN AN ORBIT GALAXY COMPLEX 4X10 AND 3.5X9 (FROM J+J). UPON IMPLANTING THE THIRD COIL, IT CAME OUT OF THE NECK OF THE ANEURYSM AND A HYPERFORM BALLOON WAS USED TO PUSH AND PLACE THE COIL BACK INTO THE ANEURYSM. AT THIS TIME, THE PHYSICIAN NOTICED THAT THE ANEURYSM HAD RUPTURED AND HE USED OTHER COILS TO COMPLETE THE PROCEDURE. NO OTHER INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON SYSTEM OCCLUSION BALLOON CATHETER NUF EV3 NEUROVASCULAR 104-4470 9609309

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability