BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX?

    MDR report key: 3841245 · Received May 30, 2014

    Report

    Report Number
    2134265-2014-02937
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 5, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY THE MFR: RETURNED PRODUCT CONSISTED OF A VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH A VERIFLEX SHELF BOX. THE BATCH NUMBER ON THE RETURNED PACKAGING AND DEVICE MATCHED THE REPORTED BATCH NUMBER. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WAS A COMPLETE HYPOTUBE SEPARATION 47.5CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THERE WERE MULTIPLE KINKS THROUGHOUT THE HYPOTUBE AND SHAFT OF THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE KINKS AND BROKEN HYPOTUBE. 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 SHAFT BREAK OCCURRED. A 4.50MM X 32MM VERIFLEX¿ STENT DELIVERY SYSTEM WAS SELECTED. DURING ADVANCING, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318946 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893432450 16207724

    Patients

    Seq Age Sex Outcome Treatment
    1