BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL

    MDR report key: 864934 · Received September 26, 2006

    Report

    Report Number
    6000093-2006-01896
    Event Type
    Malfunction
    Date Received
    September 26, 2006
    Date of Event
    August 29, 2006
    Report Date
    August 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8151341 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE QUANTUM MAVERICK MONORAIL BALLOON RUPTURED AT 9 ATMS UPON FIRST INFLATION. THE LESION WAS LOCATED IN THE 90% STENOSED AND NON-CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER QUANTUM MAVERICK BALLOON. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL PTCA CATHETER LOX BOSTON SCIENTIFIC CORP. 20MMX 3.0MM 8151341

    Patients

    Seq Age Sex Outcome Treatment
    1 YR