BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2013525 · Received March 10, 2011

    Report

    Report Number
    2134265-2011-00583
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 A PERCUTANEOUS INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE SEVERELY CALCIFIED LESION WAS LOCATED IN AN UNKNOWN VESSEL. AN UNKNOWN STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THE 8MM X 2.5MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS SELECTED TO POST DILATE THE PREVIOUSLY IMPLANTED STENT. THE BALLOON CATHETER WAS ADVANCED AND DURING THE FIRST INFLATION A BALLOON RUPTURE OCCURRED AT 20 ATMS. THE BALLOON CATHETER WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008250 12265722

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, SION