BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1172344 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02728
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. THE RETURNED DEVICE WAS IN 2 PIECES. THE DEVICE MEASURED 89CM FROM THE DISTAL EDGE OF THE STRAIN RELIEF TO THE SHAFT BREAK. THE SECOND PIECE MEASURED 54.5CM FROM THE SHAFT BREAK TO THE DISTAL END OF THE TIP. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE SHAFT BREAK DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, A SHAFT BREAK OCCURRED. THE 70% STENOTIC, DENOVO, ECCENTRIC AND CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 4.5MM X 40MM. VASCULAR ACCESS WAS GAINED THROUGH THE RADIAL ARTERY. UPON ATTEMPT TO ADVANCE THE QUANTUM MAVERICK MONORAIL 15MM X 4.0MM BALLOON CATHETER ACROSS A PREVIOUSLY PLACED STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE SHAFT BROKE. THE BALLOON CATHETER WAS CONTAINED WITH IN THE GUIDE CATHETER AND THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICES TOGETHER WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE AND TWO TAXUS STENTS WERE IMPLANTED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S STATUS WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X4.0 MM 9332940

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR BMW GUIDE WIRE| XBRCA 6FR GUIDE CATHETER