BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2201522 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02817
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ESCAPE NITINOL STONE RETRIEVAL BASKET. ANALYSIS OF THE RETURNED ESCAPE NITINOL STONE RETRIEVAL BASKET REVEALED THAT THE DEVICE WAS DEFECTIVE. THE BASKET AND ALL OF THE BASKET WIRES WERE PRESENT; HOWEVER, ONE OF THE BASKET WIRES WAS BROKEN. THE BROKEN WIRE WAS ATTACHED. THE BASKET OPENED FULLY AND CLOSED WITHOUT ISSUE. PER THE EVENT DESCRIPTION, THE DEFECT WAS IDENTIFIED INSIDE THE SEALED POUCH; HOWEVER, THE POUCH WAS OPENED WHEN RECEIVED, SO IT COULD NOT BE CONFIRMED THAT THE DEFECT WAS CAUSED DURING TRANSIT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS UNPACKING/HANDLING DAMAGE. IT SHOULD ALSO BE NOTED THAT A NITINOL WIRE BREAKING, BUT NOT DETACHING FROM THE DEVICE IS NOT A MEDWATCH REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE NITINOL STONE RETRIEVAL BASKET WAS TO BE USED IN A UROLOGY SURGERY FOR SPECIMEN RETRIEVAL PROCEDURE. THERE WAS NO PATIENT INFORMATION REPORTED OR ABLE TO BE OBTAINED. ACCORDING TO THE COMPLAINANT, THE BASKET FROM THE ESCAPE NITINOL STONE RETRIEVAL BASKET WAS FOUND TO BE DAMAGED IN ITS SEALED PACKAGE WHILE UNPACKING THE DEVICE PRIOR TO THE PROCEDURE. THE DATE OF THE EVENT AND/OR THE PROCEDURE AS WELL AS HOW THE PROCEDURE WAS COMPLETED WAS ALSO UNABLE TO BE OBTAINED. NO STATUS ON PATIENT COMPLICATIONS OR CONDITION WAS AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE NITINOL STONE RETRIEVAL BASKET WAS TO BE USED IN A UROLOGY SURGERY FOR SPECIMEN RETRIEVAL PROCEDURE. THERE WAS NO PATIENT INFORMATION REPORTED OR ABLE TO BE OBTAINED. ACCORDING TO THE COMPLAINANT, THE BASKET FROM THE ESCAPE NITINOL STONE RETRIEVAL BASKET WAS FOUND TO BE DAMAGED IN ITS SEALED PACKAGE WHILE UNPACKING THE DEVICE PRIOR TO THE PROCEDURE. THE DATE OF THE EVENT AND/OR THE PROCEDURE AS WELL AS HOW THE PROCEDURE WAS COMPLETED WAS ALSO UNABLE TO BE OBTAINED. NO STATUS ON PATIENT COMPLICATIONS OR CONDITION WAS AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 14119969

    Patients

    Seq Age Sex Outcome Treatment
    1