BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2973576 · Received February 22, 2013

    Report

    Report Number
    3005099803-2013-00911
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ESCAPE RETRIEVAL BASKET REVEALED THE WORKING LENGTH WAS CUT APPROXIMATELY 57.3CM FROM THE DISTAL END OF THE BLACK HEAT SHRINK. THE DETACHED FRAGMENT OF THE SHEATH WAS APPROXIMATELY 59.5CM LONG. THE BASKET EXTENDED FROM THE DISTAL END OF THE DETACHED FRAGMENT WHEN RECEIVED AND THE DISTAL END OF THE SHEATH APPEARED TO BE FRAYED. THE WORKING LENGTH COULD NOT BE ACCURATELY MEASURED AND IT COULD NOT BE DETERMINED IF ANY OF THE DISTAL END OF THE SHEATH DETACHED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE BASKET AND ALL BASKET WIRES WERE PRESENT AND ATTACHED. SEVERAL KINKS WERE IDENTIFIED ALONG THE WORKING LENGTH OF BOTH SECTIONS OF THE OUTER SHEATH. THERE WAS A SIGNIFICANT KINK APPROXIMATELY 2.5CM FROM THE PROXIMAL END OF THE DETACHED FRAGMENT OF THE OUTER SHEATH; THE KINK WAS COLLAPSED. THERE WAS A TORQUE MARK PRESENT ON THE HANDLE CAP TO INDICATE THE APPLICATION OF THE TORQUING PROCESS, AND THE HANDLE CANNULA WAS VISIBLE THROUGH THE HANDLE. A FUNCTIONAL EVALUATION WAS PERFORMED AND WHEN THE HANDLE THE WIRE WOULD MOVE FREELY THROUGH THE SHEATH. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    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) 013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER CAPTURING A STONE, THE SHEATH TORE AND THE BASKET WAS UNABLE TO OPEN TO RELEASE THE STONE. THE PHYSICIAN CUT THE BASKET WIRE AND SHEATH FROM THE HANDLE AND REMOVED THE SCOPE AND SHEATH FROM THE PATIENT. AFER REPLACING THE SCOPE NEXT TO THE BASKET WIRE INSIDE OF THE PATIENT IT WAS CONFIRMED THAT THE STONE WAS SUCCESSFULLY RELEASED FROM THE BASKET. THE BASKET WIRE, WITH BASKET ATTACHED, WAS REMOVED FROM THE PATIENT AN ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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, DURING THE PROCEDURE, AFTER CAPTURING A STONE, THE SHEATH TORE AND THE BASKET WAS UNABLE TO OPEN TO RELEASE THE STONE. THE PHYSICIAN CUT THE BASKET WIRE AND SHEATH FROM THE HANDLE AND REMOVED THE SCOPE AND SHEATH FROM THE PATIENT. AFER REPLACING THE SCOPE NEXT TO THE BASKET WIRE INSIDE OF THE PATIENT IT WAS CONFIRMED THAT THE STONE WAS SUCCESSFULLY RELEASED FROM THE BASKET. THE BASKET WIRE, WITH BASKET ATTACHED, WAS REMOVED FROM THE PATIENT AN ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    78616 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010

    Patients

    Seq Age Sex Outcome Treatment
    1