BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OVER-THE-WIRE PTCA CATHETER

    MDR report key: 1171355 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02689
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/162
    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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.25 X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE FIRST DIAGONAL (D1) BRANCH AND REPORTED TO HAVE RUPTURED UPON THE SECOND INFLATION AT 10 ATM'S; THE DURATION OF THE INFLATION IS UNKNOWN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD". FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OVER-THE-WIRE PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15/2.25 11743368

    Patients

    Seq Age Sex Outcome Treatment
    1