BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX?

    MDR report key: 3981374 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04605
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A VERIFLEX SDS WITH STENT. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. DEVICE ANALYSIS DETERMINED THE DAMAGE OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. MICROSCOPIC EXAMINATION REVEALED THAT THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE DAMAGED. THERE WERE NUMEROUS STRUTS THAT WERE FLARED AND BENT. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT 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 THAT STENT DAMAGE OCCURRED. A 3.50MM X 16MM VERIFLEX¿ STENT WAS SELECTED. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE STENT TINES WERE SPLAYED. THE DEVICE WAS NOT PREPPED AND WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50MM X 16MM VERIFLEX¿ STENT WAS SELECTED. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE STENT TINES WERE SPLAYED. THE DEVICE WAS NOT PREPPED AND WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458317 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893416350 16957714

    Patients

    Seq Age Sex Outcome Treatment
    1