BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TRI-LOBE BALLOON CATHETER

    MDR report key: 1903504 · Received November 16, 2010

    Report

    Report Number
    2017233-2010-00508
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 16, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ACCORDING TO THE GORE TRI-LOBE BALLOON CATHETER INSTRUCTIONS FOR USE, EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL\RUPTURE, OR PT DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT DEBRANCHING SURGERY USING VASCULAR GRAFTS. THEN REPAIR OF A THORACIC AORTIC ANEURYSM WAS PERFORMED WHERE TWO GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED. THE BRACHIOCEPHALIC, LEFT COMMON CAROTID AND THE LEFT SUBCLAVIAN ARTERY WERE INTENTIONALLY COVERED. A GORE TRI-LOBE BALLOON WAS USED TO BALLOON THE DEVICES AND WAS OVERINFLATED, CAUSING THE ANASTOMOSIS SITE BETWEEN THE DEBRANCHED VASCULAR GRAFT AND THE AORTA TO RUPTURE. AN OPEN THORACIC SURGERY TO TREAT THE HEMORRHAGE WAS PERFORMED. THE TEAR OF ANASTOMOSIS SITE WAS SUTURED AGAIN AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TRI-LOBE BALLOON CATHETER DQY/CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES WLG460 7335006

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R