BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 902313 · Received August 23, 2007

    Report

    Report Number
    6000093-2007-01573
    Event Type
    Death
    Date Received
    August 23, 2007
    Date of Event
    July 11, 2007
    Report Date
    August 1, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE USER FACILITY, THUS A RETURNED PRODUCT ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2954755-2007-00036. IT WAS REPORTED THAT DURING A PTCA OF A SVG, THE PATIENT DEVELOPED CARDIAC TAMPONADE AND LATER EXPIRED. THE VESSEL WAS DILATED WITH A 3.5X30MM QUANTUM MAVERICK BALLOON CATHETER. FOLLOWING BALLOON INFLATION, THE PATIENT COMPLAINED OF BACK PAIN AND RIGHT ARM DISCOMFORT. REPEAT ANGIOGRAPH SHOWED A DISTAL PERFORATION OF THE VEIN GRAFT IN THE VICINITY OF THE TIP OF THE FILTERWIRE, DISTAL TO THE SITE OF BALLOON DILATION. IT IS BELIEVED THAT THE BALLOON "WATERMELON SEEDED" DISTALLY DURING INFLATION, THEREBY PUSHING THE FILTERWIRE DISTALLY. THE PATIENT DEVELOPED CARDIAC TAMPONADE DESPITE THE USE OF A COVERED STENT AND A PERICARDIOCENTESIS. THE PATIENT WAS INTUBATED, IABP WAS INSERTED, AND CPR STARTED. THE PATIENT CARDIOVERTED TWICE AND PERICARDIOCENTESIS WAS DONE. THE PATIENT WAS SENT FOR SURGERY TWO HOURS AFTER PERFORATION WAS DISCOVERED. TWO HOURS LATER, THE PATIENT DIED BEFORE SURGICAL DRAINAGE COULD BE PERFORMED. THE DOCUMENTED CAUSE OF DEATH WAS CARDIAC TAMPONADE, AORTO-CORONARY VEIN GRAFT PERFORATION, AORTO-CORONARY VEIN GRAFT STENTING, STENOSIS OF VEIN GRAFT FROM PRIOR CORONARY BYPASS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death JOMED COVERED STENT