BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2580325 · Received May 18, 2012

    Report

    Report Number
    3005099803-2012-01757
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ESCAPE RETRIEVAL BASKET REVEALED THAT THE DEVICE WAS RETURNED WITH THE TRAY INSIDE ITS ORIGINAL, PARTIALLY OPENED, POUCH. VISUAL ASSESSMENT FOUND THAT THE POUCH WAS PARTIALLY OPENED AT THE CHEVRON END. THERE WAS EVIDENCE OF ADHESION ON THE CLEAR MYLAR SIDE OF THE POUCH, AND SOME OF THE TYVEK REMAINED ATTACHED AT THE SEAL. THERE WERE NO BREAKS IN THE TYVEK THAT REMAINED ATTACHED TO THE MYLAR. THERE WERE WRINKLES IN THE CENTER OF THE CHEVRON AREA THAT WERE CONSISTENT WITH A POUCH THAT HAD BEEN PULLED OPEN AT THE CHEVRON. ALL OF THE OTHER SEALS WERE FULLY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME ASPECT OF HANDLING PRIOR TO USE, AS THE PACKAGED DEVICES ARE 100% INSPECTED FOR INTEGRITY DURING MANUFACTURING. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING UNPACKING IN THE STOCK ROOM, IT WAS NOTED THAT THE SEAL ON THE POUCH OF THE DEVICE WAS NOT ADHERED PROPERLY. IT IS UNKNOWN IF THERE WAS ANY DAMAGE NOTED TO THE BOX THE DEVICE WAS SHIPPED IN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING UNPACKING IN THE STOCK ROOM, IT WAS NOTED THAT THE SEAL ON THE POUCH OF THE DEVICE WAS NOT ADHERED PROPERLY. IT IS UNKNOWN IF THERE WAS ANY DAMAGE NOTED TO THE BOX THE DEVICE WAS SHIPPED IN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 15084185

    Patients

    Seq Age Sex Outcome Treatment
    1