BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX?

    MDR report key: 3932273 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04026
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 6, 2013
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED 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 VIA FACILITY MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 3.50MM X 16MM VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION. WHILE TRYING TO ADVANCE THE DEVICE TO THE TARGET LESION, IT WAS NOTED THAT THE SHAFT OF THE SDS BROKE INTO TWO PIECES. THE BROKEN CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410452 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893416350 15817992

    Patients

    Seq Age Sex Outcome Treatment
    1