BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE MAX BALLOON DILATATION CATHETER

    MDR report key: 1062514 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01703
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 24, 2008
    Report Date
    May 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, DEFLATION ISSUES OCCURRED. THE 90% STENOSED LESION WAS DESCRIBED AS AN ANASTOMIC STRICTURE IN THE SHUNT LOCATED IN THE MODERATELY TORTUOUS LEFT ANTEBRACHIUM. THE BLUE MAX BALLOON WAS INFLATED 4 TIMES TO 20 ATMS. FOLLOWING THE FOURTH INFLATION, THE BLUE MAX BALLOON COULD NOT BE DEFLATED. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON WITH AN "INDOFLATOR", BUT THAT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN PUSHED ON THE BALLOON THROUGH SKIN SURFACE AND WAS ABLE TO DEFLATE THE BALLOON. THE DEFLATED BALLOON WAS THEN REMOVED FROM THE PT WITH NO FURTHER INCIDENT, AND THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS 'GOOD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 11357067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INFLATION DEVICE, EVEREST| CLINICAL| GUIDEWIRE: INTERTHROUGH MEASURE 0.035 150| INTRODUCER SHEATH: 6FR