BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE?

    MDR report key: 4930112 · Received July 21, 2015

    Report

    Report Number
    3005099803-2015-02062
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE¿ BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, PART OF THE BASKET SHEATH BROKE INTO PIECES AND FELL INSIDE THE PATIENT. THE DETACHED PIECES WERE COMPLETELY FLUSHED OUT WITH WATER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472708 ESCAPE? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 17920482

    Patients

    Seq Age Sex Outcome Treatment
    1