BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2884133 · Received December 21, 2012

    Report

    Report Number
    3005099803-2012-06030
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED CUT AT THE DISTAL END OF THE T-FITTING CANNULA. THE WIRE BASKET ASSEMBLY, WHICH WAS RECEIVED SEPARATED FROM THE COIL ASSEMBLY, WAS CUT APPROXIMATELY 54.5CM FROM THE CRIMP SLEEVE. FURTHER ANALYSIS OF THE BASKET REVEALED THE DISTAL TIP TO BE INTACT, AND THE BASKET WIRES TO BE BENT AND UNEVENLY SPACED. ADDITIONALLY, THE SIDECAR RX (GUIDEWIRE LUMEN) PRESENTED WITH PUSHBACK (LIKELY DUE TO OPERATIONAL CONTEXT). THE HANDLE ASSEMBLY, WHICH RETURNED BENT AND WITH THE LABEL REMOVED EXPOSING THE SET SCREWS, WAS FOUND TO HAVE A CRACKED/BROKEN THUMB RING. FURTHERMORE, THE HANDLE CANNULA HAD BEEN PULLED OUT OF THE FINGER RING PORTION OF THE HANDLE ASSEMBLY. DEEP SCORE/DRAG MARKS WERE PRESENT ON THE CANNULA AS A RESULT OF IT BEING FORCIBLY REMOVED FROM THE SET SCREWS. HOWEVER, THE SET SCREWS REMAINED PROPERLY PLACED IN THE HANDLE ASSEMBLY. FUNCTIONALLY, THE DEVICE WAS NOT ABLE TO BE TESTED DUE TO THE RETURN CONDITION. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT THAT THE HANDLE BROKE PRIOR TO STONE LITHOTRIPSY. THE DEVICE IS DESIGNED SO THAT THE BASKET TIP DETACHES IF THE STONE CANNOT BE CRUSHED WHICH, BASED ON THE DEVICE ANALYSIS, FAILED TO OCCUR IN THIS CASE. HOWEVER, A MATERIAL REVIEW OF THE SUB-ASSEMBLY COMPONENTS USED WITHIN THE REPORTED LOT CONFIRMED THAT THE TIP AND PULLWIRE JOINTS CONFORMED TO THE MANUFACTURING SPECIFICATION. THE DEVICE DAMAGE LIKELY OCCURRED DUE TO A COMBINATION OF USER TECHNIQUE, TORTUOUS ANATOMY AND OTHER PROCEDURAL FACTORS LIKELY CAUSING THE TENSILE FORCE APPLIED BY THE USER TO NOT BE FULLY DISTRIBUTED THROUGHOUT THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - OLYMPUS LITHOCRUSH. 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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER CAPTURING A STONE WITHIN THE BASKET, LITHOTRIPSY WAS ATTEMPTED, BUT THE CALCULI WAS NOT ABLE TO BE BROKEN UP. ADDITIONALLY, THE BASKET PULLWIRES BROKE AT THE LEVEL OF THE HANDLE, WHICH LEFT THE HANDLE NON-FUNCTIONAL. WIRE CUTTERS WERE THEN USED TO CUT OFF THE HANDLE. A MECHANICAL LITHOTRIPTER ("LITHOCRUSH" DEVICE) WAS ATTACHED TO THE EXPOSED WIRES AND LITHOTRIPSY WAS ATTEMPTED WHICH SUCCESSFULLY FORCED THE CLOSURE OF THE BASKET. THE REMAINING SECTION OF BASKET AND STONE FRAGMENTS WERE THEN WITHDRAWN FROM THE PATIENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER CAPTURING A STONE WITHIN THE BASKET, LITHOTRIPSY WAS ATTEMPTED, BUT THE CALCULI WAS NOT ABLE TO BE BROKEN UP. ADDITIONALLY, THE BASKET PULLWIRES BROKE AT THE LEVEL OF THE HANDLE, WHICH LEFT THE HANDLE NON-FUNCTIONAL. WIRE CUTTERS WERE THEN USED TO CUT OFF THE HANDLE. A MECHANICAL LITHOTRIPTER ('LITHOCRUSH' DEVICE) WAS ATTACHED TO THE EXPOSED WIRES AND LITHOTRIPSY WAS ATTEMPTED WHICH SUCCESSFULLY FORCED THE CLOSURE OF THE BASKET. THE REMAINING SECTION OF BASKET AND STONE FRAGMENTS WERE THEN WITHDRAWN FROM THE PATIENT TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 15515864

    Patients

    Seq Age Sex Outcome Treatment
    1