BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE?

    MDR report key: 2994337 · Received March 8, 2013

    Report

    Report Number
    3005099803-2013-01208
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL REVIEW OF THE COMPLAINT INFORMATION, THE PRIORITY OF THIS EVENT WILL BE CHANGED TO MALFUNCTION FROM SERIOUS INJURY AS NO MEDICAL INTERVENTION WAS REQUIRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER CAPTURING STONES IN THE BASKET, THE PHYSICIAN WENT TO REMOVE THE DEVICE AND THE BASKET DETACHED. THE PHYSICIAN WAITED FOR THE CONTINUOUS FLOW OF FLUID TO FLUSH THROUGH THE PATIENT AND THEN NOTED THE STONES HAD FLUSHED OUT OF THE BASKET. THE EMPTY BASKET WAS THEN FOUND HANGING OUT OF THE PATIENT¿S URETHRA; THE PHYSICIAN PULLED THE BASKET OUT OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT¿S CONDITION POST PROCEDURE WAS FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN ESCAPE RETRIEVAL BASKET USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER CAPTURING STONES IN THE BASKET, THE PHYSICIAN WENT TO REMOVE THE DEVICE AND THE BASKET DETACHED. THE PHYSICIAN WAITED FOR THE CONTINUOUS FLOW OF FLUID TO FLUSH THROUGH THE PATIENT AND THEN NOTED THE STONES HAD FLUSHED OUT OF THE BASKET. THE EMPTY BASKET WAS THEN FOUND HANGING OUT OF THE PATIENT'S URETHRA; THE PHYSICIAN PULLED THE BASKET OUT OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT¿S CONDITION POST PROCEDURE WAS FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99668 ESCAPE? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 15573140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention