BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1040830 · Received May 9, 2008

    Report

    Report Number
    3005099803-2008-00449
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT NOT YET EVALUATED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. THE MARCH 2008 15-MONTH LITHOTRIPTER BASKET PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE PRODUCT DFU SITES THE FOLLOWING: NOTE: THE TRAPEZOID 3X6 BASKET IS DESIGNED FOR CRUSHING CALCULUS LARGER THAN 1.5 CM (15 MM) IN DIAMETER. ATTACH THE TRAPEZOID RX BASKET TO THE ALLIANCE II DEVICE BY ALIGNING THE THUMB RING AND THE HANDLE RING WITH THE HEEL PLATE AND THE BODY PORTION OF THE ALLIANCE II RESPECTIVELY. EMERGENCY PRECAUTIONS: IN THE EVENT THAT THE TRAPEZOID RX BASKET WILL NOT CRUSH THE CALCULUS AND THE BASKET TIP HAS NOT DISENGAGED, USE THE FOLLOWING GUIDELINES: IF THE CALCULUS CAN BE REMOVED: RELEASE THE CALCULUS FROM THE BASKET, RETRACT THE BASKET INTO THE CATHETER AND REMOVE THE TRAPEZOID DEVICE. IF THE CALCULUS CANNOT BE REMOVED FROM THE BASKET: USING WIRE CUTTING PLIERS, CUT THE HANDLE OFF THE BASKET SHEATH AND ENDOSCOPE TOGETHER, LEAVING THE BASKET WIRE BEHIND WITH THE CALCULUS IN SITU. FOLLOW STANDARD SURGICAL CONSIDERATIONS FOR ENDOSCOPIC CALCULUS REMOVAL SUCH AS ATTACHING THE SOHENDRA LITHOTRIPSY SYSTEM.

    Description of Event or Problem · 1

    A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT, FOLLOWING "EST PROCEDURE, THIS DEVICE WAS INTRODUCED OVER A GUIDEWIRE [MANUFACTURER UNKNOWN] TO [THE] COMMON BILE DUCT. AFTER THE DEVICE WAS CAUGHT THE ... APPROXIMATELY 1.5CM ... STONE, [THE PHYSICIAN] TRIED TO CRUSH IT WITH THIS DEVICE [BY] GRASPING THE [ALLIANCE HANDLE]. THE ALLIANCE HANDLE [WAS ACTUATED] UP TO THE LIMIT, [BUT THE TIP COULD NOT BE DETACHED, AS INTENDED]. TO MAKE THE TIP TO DETACH FROM THE DEVICE ..., [THE PHYSICIAN MANIPULATED] THE HANDLE ... WITH FORCE. THEN, ITS WAS NOT [ED] THAT THE HANDLE WAS DEFORMED. AFTER THIS INCIDENT, [WHILE] HOLDING THE STONE INSIDE THE BASKET, IT WAS REMOVED FROM PAPILLA WITH FORCE." THE PHYSICIAN WAS ABLE TO DETACH THE TIP AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT INJURIES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510890 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK