BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 9919334 · Received April 3, 2020

    Report

    Report Number
    3007284313-2020-00092
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    March 6, 2020
    Report Date
    May 21, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5. PMA/510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE. ADDITIONALLY, THE IFU STATES: EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL RUPTURE, OR PATIENT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER STENT GRAFTS WERE IMPLANTED, THE TOUCH UP BALLOONING WAS PERFORMED BY A GORE® MOLDING & OCCLUSION BALLOON (MOB). AFTER TOUCHING UP IN THE LEFT COMMON ILIAC ARTERY, THE BLOOD PRESSURE BECAME DECREASED. IT WAS CONFIRMED THAT THE LEFT COMMON ILIAC ARTERY WAS RUPTURED. AS A TREATMENT, THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND AN ADDITIONAL STENT GRAFT WAS EXTENDED INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN ADMITTED THAT THE LEFT COMMON ILIAC ARTERY RUPTURE WAS DUE TO OVERINFLATION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385881 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES MOB37 18821529 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O