BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1220273 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04181
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF BY THE HOSP; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE COMPLAINT DEVICE THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE 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 CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 3.75X8MM QUANTUM MAVERICK BALLOON CATHETER TO THE LESION AND INFLATED IT TO 20ATMS. THEN ON THE SECOND INFLATION, THE PHYSICIAN INFLATED THE BALLOON TO 20ATMS FOR TEN SECONDS AND THE BALLOON RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 3.75X8MM QUANTUM MAVERICK BALLOON CATHETER AND THE DEPLOYMENT OF A NON-BSC STENT. PT STATUS IS REPORTED AS "NO PROBLEM".

    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 8X3.75 MM 11796962

    Patients

    Seq Age Sex Outcome Treatment
    1