BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1913879 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05016
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS RECEIVED DAMAGED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS RECEIVED THE OUTER BOX WAS INTACT, BUT THE DEVICE WAS DAMAGED/CRUSHED. THE EXACT DAMAGE COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE DAMAGE SEEMED TO HAVE OCCURRED PRIOR TO THE SHIPPING PROCESS. THERE WAS NO PROCEDURE UNDERWAY OR PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516750 13620994

    Patients

    Seq Age Sex Outcome Treatment
    1