BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1873178 · Received October 18, 2010

    Report

    Report Number
    2134265-2010-04489
    Event Type
    Death
    Date Received
    October 18, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - AS A DEVICE HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION AND DEATH OCCURRED. THE PATIENT PRESENTED WITH ISCHEMIA AND UNSTABLE ANGINA. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED CONCENTRIC DE NOVO LESION MEASURING 26MM IN LENGTH WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY TO LEFT MAIN ARTERY. THE LESION WAS PREDILATED WITH A 3.5X20MM APEX BALLOON. A 3.5X28MM PROMUS STENT WAS DEPLOYED AT 9 ATMS FOR 30 SECONDS. THE STENT DELIVERY SYSTEM BALLOON WAS AGAIN INFLATED TO 12 ATMS FOR 20 SECONDS. A 4.5X15MM QUANTUM MAVERICK BALLOON WAS ADVANCED TO THE LESION FOR POST-DILATION AND INFLATED TO 12 ATMS FOR 20 SECONDS, PULLED BACK INTO THE GUIDE CATHETER AND THEN READVANCED TO THE LESION AND INFLATED AGAIN TO 12 ATMS FOR 20 SECONDS. AFTER THE FIRST INFLATION, A VESSEL PERFORATION OCCURRED. INTEGRILIN WAS STOPPED, HEPARIN WAS REVERSED AND A NON BSC STENT GRAFT WAS DEPLOYED SEALING THE PERFORATION. THE PATIENT BECAME HYPOTENSIVE AND DEVELOPED PERICARDIAL TAMPONADE. DOPAMINE WAS ADMINISTERED AND AN EMERGENCY PERICARDIAL WINDOW WAS PERFORMED REVEALING NO FREE BLOOD IN THE PERICARDIUM. APPROXIMATELY 30 MINUTES LATER, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015450 12981415

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death 6F CORDIS BRITE TIP XB LAD GUIDE CATHETER| WHISPER ES GUIDE WIRE| 3.5X20MM APEX BALLOON| 3.5X28MM PROMUS STENT