BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUALIZER OCCLUSION BALLOON CATHETER

    MDR report key: 2992137 · Received March 1, 2013

    Report

    Report Number
    2992137
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE BTRO (BALLOON OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION), THERE WAS A BALLOON FAILURE WHICH LED TO THE LEAKING OF THE SCLEROSING AGENT INTO THE PORTOSYSTEMIC SYSTEM AND INTO THE PULMONARY VASCULATURE.THE PATIENT BECAME BRADYCARDIC AND HER OXYGENATION SATURATION DROPPED INTO THE 70S. SHE WAS INTUBATED BY ANESTHESIA WITH IMPROVEMENT IN HER O2 SATURATIONS AND HEART RATE TO BASELINE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BALLOON OCCLUDED RETROGRADE OBLITERATION (BRTO) OF THE GASTRO-SPLENO-RENAL SHUNT WITH POSSIBLE EMBOLIZATION OF COMPETING SYSTEMIC COLLATERALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89329 EQUALIZER OCCLUSION BALLOON CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R THY RELATED TO END-STAGE LIVER DISEASE.| THIS PATIENT WAS VERY ILL WITH HEPATIC ENCEPHALOPA