BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1153193 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02546
    Event Type
    Death
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A DISSECTION AND PT DEATH OCCURRED. THE LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PERCENT OF THE STENOSIS OF THE LESION, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNK. ACCESS WAS OBTAINED VIA AN UNSPECIFIED FEMORAL ARTERY. IT WAS NOT KNOWN IF THE LESION WAS PRE-DILATED. DUE TO THE LENGTH OF THE LESION, ANOTHER MFR'S 2.5MM X 28MM AND 2.75MM X 23MM STENTS WERE PLACED OVERLAPPING EACH OTHER. FOLLOWING STENT DEPLOYMENT, THE QUANTUM MAVERICK 2.5MM X 15MM BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. THE ATMS THE BALLOON REACHED ON THE FIRST INFLATION IS UNK. THE BALLOON WAS INFLATED TO 32 ATMS ON THE SECOND INFLATION, WHICH IS ABOVE THE DEVICE'S RATED BURST PRESSURE, AFTER WHICH TIME A DISSECTION WAS NOTED IN THE LAD. THE PHYSICIAN ATTEMPT TO CONTROL THE DISSECTION BY PLACING ANOTHER MFR'S STENT OF UNK SIZE INSIDE THE TWO PREVIOUSLY PLACED STENTS, HOWEVER, THIS WAS UNSUCCESSFUL IN CONTROLLING THE DISSECTION. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE, UPON OPENING THAT PT'S CHEST, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X2.5 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 2.75MM X 23MM CYPHER STENT| 2.5MM X 28MM CYPHER STENT| 3RD CYPHER STENT OF UNK SIZE