BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINTER BALLOON

    MDR report key: 1090964 · Received July 28, 2008

    Report

    Report Number
    MW5007865
    Date Received
    July 28, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 28, 2008
    Manufacturer
    *
    Product Code
    LOX
    Report Source
    Voluntary report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP RECEIVED A COMPLAINT THAT INCLUDED A SPRINTER BALLOON CATHETER ON 07/24/2008. THE FOLLOWING IS THE INFO RECEIVED BY BOSTON SCIENTIFIC: EVENT DESCRIPTION - THE PRIMARY DISEASE WAS AP (ANGINA PECTORIS). THE LESION WAS 99% OF STENOSIS WITH A SEVERE CALCIFICATION AND MODERATE TORTUOUS IN LAD MIDDLE. THE APEX BALLOON WAS NOT ABLE TO CROSS THE LESION. ALSO WHEN THE PHYSICIAN ATTEMPTED TO REMOVE AIR FROM INSIDE OF THE BALLOON CATHETER AT INSIDE THE PT, BLOOD FLOWED INTO THE CATHETER. SO THE PHYSICIAN CHANGED THE APEX BALLOON TO SPRINTER 1.5X15MM BALLOON. BUT THE SPRINTER RUPTURED. EVENTUALLY, THE LESION WAS DILATED BY HIRYU 2.5X20MM BALLOON AT 20 ATM, AND CYPHER 2.5X28MM STENT WAS IMPLANTED IN THE LESION. ACCORDING TO THE PHYSICIAN, CAUSE OF THE RUPTURE MIGHT BE CALCIFIED LESION. THE RUPTURED BALLOONS WERE REMOVED INTACT FROM INSIDE THE PT. THE PT HAD NO ANY INJURIES AND COMPLICATIONS AT THE PROCEDURE. CONCOMITANT DEVICES: GC 7FR LAUNCHER SL4/GW: RUNTHROUGH FLOPPY / BC: SPRINTER 1.5X15, HIRYU 2.5X20/STENT: CYPHER 2.5X28. BOSTON SCIENTIFIC CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER BALLOON BALLOON LOX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1