BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCAPE¿

    MDR report key: 2974326 · Received February 22, 2013

    Report

    Report Number
    3005099803-2013-00912
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ESCAPE RETRIEVAL BASKET REVEALED THE DEVICE WAS DISASSEMBLED. THE BASKET WAS EXTENDED FROM THE SHEATH AND THE OUTER SHEATH WAS TORN/DETACHED AT THE PROXIMAL END. THE DETACHED SHEATH WAS KINKED AND BUCKLED IN SEVERAL LOCATIONS; IT MEASURED APPROXIMATELY 121.4CM. THE BASKET WIRE SUB-ASSEMBLY WAS DETACHED FROM THE HANDLE CANNULA AND A FRAGMENT OF THE HANDLE CANNULA, APPROXIMATELY 6.3CM, WAS STUCK IN THE HANDLE LUER CAP/SHEATH LUER. FURTHER EXAMINATION NOTED THE BASKET WIRE SUB-ASSEMBLY WAS BENT. THREE OF THE BASKET LEGS WERE BENT/KINKED AND ONE OF THE WIRES WAS BROKEN APPROXIMATELY 2MM FROM THE DISTAL END AND APPROXIMATELY 3MM FROM THE PROXIMAL END. THE MIDDLE SECTION OF THE BROKEN WIRE WAS MISSING AND NOT RETURNED FOR EVALUATION. UNDER EXAMINATION, THE BROKEN ENDS OF THE BASKET WIRE WERE DISCOLORED AND CONSISTENT WITH THOSE THAT WERE CONTACTED BY LASER. THERE WAS A TORQUE MARK PRESENT ON THE HANDLE CAP TO INDICATE THE APPLICATION OF THE TORQUING PROCESS AND THERE WERE PROMINENT INDENTIONS ON THE PROXIMAL END OF THE PINCH VISE TO INDICATE THE HANDLE CANNULA WAS PROPERLY PLACED DURING MANUFACTURING ASSEMBLY. THE BASKET WIRE SUB-ASSEMBLY COULD NOT BE REMOVED FROM THE SHEATH; MOST LIKELY DUE TO THE BUCKLED AND KINKED SHEATH. A FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE DEFECTS NOTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. AS THE DEVICE EXHIBITED SIGNS CONSISTENT WITH THAT WHICH HAD BEEN IN CONTACT WITH A LASER, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS USE/USER ERROR.

    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, WHEN THE DEVICE WAS OPENED INSIDE THE PATIENT, WHILE GRASPING FOR THE STONE, TWO WIRES BROKE OFF THE BASKET. THE WIRES WERE FLUSHED TO THE BLADDER AND SUCCESSFULLY REMOVED BY THE PHYSICIAN. IT IS UNKNOWN IF THERE WAS A LASER BEING USED DURING THE PROCEDURE OR HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS STABLE.

    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, WHEN THE DEVICE WAS OPENED INSIDE THE PATIENT, WHILE GRASPING FOR THE STONE, TWO WIRES BROKE OFF THE BASKET. THE WIRES WERE FLUSHED TO THE BLADDER AND SUCCESSFULLY REMOVED BY THE PHYSICIAN. IT IS UNKNOWN IF THERE WAS A LASER BEING USED DURING THE PROCEDURE OR HOW THE PROCEDURE WAS COMPLETED.THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78131 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 15667457

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention