BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX?

    MDR report key: 3150731 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-03862
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE INNER PACKAGING POUCH WAS NOT RECEIVED. THERE WAS A STOPCOCK ATTACHED TO THE HUB OF THE CATHETER. THERE WAS NO VISIBLE BLOOD OR CONTRAST ON THE DEVICE. THE STENT WAS SECURE BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; HOWEVER, THERE WERE SEVERAL DAMAGED STRUTS IN THE FIRST THREE (3) PROXIMAL ROWS OF STENT STRUTS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE WAS OBSERVED. WHILE UNPACKING THE 5.00MM X 20MM VERIFLEX STENT DELIVERY SYSTEM THEY DISCOVERED THAT TOWARDS THE END OF THE STENT WHERE THE PURPLE TIP IS LOCATED A WIRING MESH WAS ENTWINED AND A RAISE IN THE WIRE. THERE WAS NO PATIENT INVOLVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE WAS OBSERVED. WHILE UNPACKING THE 5.00MM X 20MM VERIFLEX STENT DELIVERY SYSTEM THEY DISCOVERED THAT TOWARDS THE END OF THE STENT WHERE THE PURPLE TIP IS LOCATED A WIRING MESH WAS ENTWINED AND A RAISE IN THE WIRE. THERE WAS NO PATIENT INVOLVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250805 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893420500 15941359

    Patients

    Seq Age Sex Outcome Treatment
    1