BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 3010001 · Received March 18, 2013

    Report

    Report Number
    3005099803-2013-01596
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE, AND THE USER HAD CUT APART THE DEVICE AT THE DISTAL END OF THE T-FITTING CANNULA. THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE COIL WAS FOUND TO BE BUCKLED IN MULTIPLE AREAS. THE WIRE BASKET ASSEMBLY WAS FULLY EXTENDED OUT THE DISTAL END OF THE COIL ASSEMBLY. AN EXAMINATION OF THE BASKET FOUND THE TIP TO BE INTACT AND THE WIRES WERE BENT AND NOT EVENLY SPACED. THE HANDLE CANNULA WAS FOUND TO HAVE BEEN PULLED OUT OF THE FINGER RING PORTION OF THE HANDLE ASSEMBLY. THE SET SCREWS WERE EXAMINED AND FOUND TO BE PROPERLY PLACED IN THE HANDLE ASSEMBLY. THE HANDLE CANNULA WAS FOUND TO HAVE BEEN CUT BY THE CUSTOMER AND THE DISTAL PORTION WAS BENT IN MULTIPLE PLACES REMAINED AND ATTACHED TO THE PULL WIRE. THE PROXIMAL PORTION OF THE HANDLE CANNULA WAS REMOVED FROM INSIDE THE T-FITTING FOR EXAMINATION. THIS PORTION PRESENTED DEEP SCORE/ DRAG MARKS FROM THE DIMPLES TO THE PROXIMAL END AS THE CANNULA HAD BEEN FORCIBLY PULLED OUT FROM THE SET SCREWS. FUNCTIONALLY THE BASKET COULD NOT BE TESTED DUE TO THE RETURN CONDITION OF THE DEVICE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. 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. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF WIRE BROKE. 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. (B)(4).

    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 PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BASKET WAS OPENED IN THE COMMON BILE DUCT, A STONE WAS CAPTURED WITH THE BASKET AND THE HANDLE OF THE BASKET WAS PLACED IN THE ALLIANCE HANDLE. WHILE ATTEMPTING TO CRUSH THE STONE THE WIRE INSIDE OF THE HANDLE BROKE. THE PHYSICIAN USED AN OLYMPUS BASKET TO CRUSH THE STONE INSIDE OF THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET AND THEN CUT THE HANDLE IN ORDER TO REMOVE IT FROM THE PATIENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    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 PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BASKET WAS OPENED IN THE COMMON BILE DUCT, A STONE WAS CAPTURED WITH THE BASKET AND THE HANDLE OF THE BASKET WAS PLACED IN THE ALLIANCE HANDLE. WHILE ATTEMPTING TO CRUSH THE STONE THE WIRE INSIDE OF THE HANDLE BROKE. THE PHYSICIAN USED AN OLYMPUS BASKET TO CRUSH THE STONE INSIDE OF THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET AND THEN CUT THE HANDLE IN ORDER TO REMOVE IT FROM THE PATIENT. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111912 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 15299104

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention