BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    MDR report key: 2151887 · Received July 7, 2011

    Report

    Report Number
    3005099803-2011-02293
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE. THE DEVICE HAD BEEN CUT AND THE DISTAL PORTION WAS NOT RETURNED. THE PULLWIRE WAS FRACTURED NEAR THE HANDLE CANNULA AND THE FRACTURED END WAS NECKED DOWN, INDICATING THAT THE WIRE MOST LIKELY SHEARED APART WHILE UNDERGOING TENSILE FORCE. THE HANDLE CANNULA HAD BEEN PROPERLY DIMPLED, AND THE SET SCREWS WERE SEATED CORRECTLY. THE SET SCREW DEPTH WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. ADDITIONALLY, DRAG MARKS WERE NOTED FROM THE DIMPLES TO THE PROXIMAL END OF THE HANDLE CANNULA, MOST LIKELY CAUSED BY THE DEVICE OPERATOR DURING DISASSEMBLY OF THE HANDLE TO MANIPULATE THE DEVICE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE WIRE BROKE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENTS AGE IS UNKNOWN, HOWEVER, THE PATIENT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF PULLWIRE BREAK. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A BILIARY STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THEY TRIED TO CRUSH A 30MMX20MM STONE DURING THE PROCEDURE, THE STONE WAS STRANGULATED INSIDE THE BASKET WIRE. THE PULLWIRE BROKE NEAR THE HANDLE. THE HANDLE WAS DISASSEMBLED AND THE PROXIMAL END OF THE WIRE WAS MANIPULATED TO REMOVE THE STONE FROM THE BASKET. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A BILIARY STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THEY TRIED TO CRUSH A 30MMX20MM STONE DURING THE PROCEDURE, THE STONE WAS STRANGULATED INSIDE THE BASKET WIRE. THE PULLWIRE BROKE NEAR THE HANDLE. THE HANDLE WAS DISASSEMBLED AND THE PROXIMAL END OF THE WIRE WAS MANIPULATED TO REMOVE THE STONE FROM THE BASKET. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890

    Patients

    Seq Age Sex Outcome Treatment
    1