BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1549794 · Received November 20, 2009

    Report

    Report Number
    2134265-2009-06551
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 22, 2009
    Report Date
    October 22, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EIGHTEEN OR OLDER. THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/ PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED, CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS "APICAL" ARTERY. A QUANTUM MAV MON 8MM X 2.5MM BALLOON CATHETER WAS ADVANCED TO TREAT THE TARGET LESION. THE BALLOON WAS INFLATED ONCE TO 12 ATMS. THE BALLOON WAS INFLATED A 2ND TIME TO 12 ATMS AND THE BALLOON RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    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 8X2.5 MM 12736018

    Patients

    Seq Age Sex Outcome Treatment
    1