BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1951354 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05797
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    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)(6). (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE 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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED CHRONIC TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 20MM X 2.5MM QUANTUM MAVERICK BALLOON CATHETER WAS INSERTED AND CROSSED THE LESION WITHOUT ISSUE. DURING AN UNKNOWN INFLATION ATTEMPT, THE BALLOON RUPTURED AT APPROXIMATELY 16 ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 H7493808020250 13365149

    Patients

    Seq Age Sex Outcome Treatment
    1