BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1171175 · Received September 22, 2008

    Report

    Report Number
    3005099803-2008-04751
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, A BASKET AND BASKET PULL-WIRE DETACHMENT AND SURGICAL INTERVENTION OCCURRED. THE LESION WAS LOCATED IN THE DISTAL COMMON BILE DUCT. THE RX LITHOTRIPTER COMPATABLE BASKET WAS ADVANCED TO THE STONE AND WAS ABLE TO SUCCESSFULLY CAPTURE THE STONE. UPON ATTEMPTING TO MANUALLY CRUSH THE STONE, THE STONE WAS UNABLE TO BE CRUSHED. THE PHYSICIAN PLACED THE HANDLE OF THE BASKET INTO A ANOTHER MFR'S PRESSURE GUN. UPON MECHANICAL CRUSHING OF THE STONE, THE DISTAL TIP OF THE BASKET FAILED TO DISENGAGE AND THE COIL OVER-SHEATH SEPARATED IN THE MID-CATHETER. THE HANDLE BROKE OFF WHICH IN TURN PULLED OFF THE OVER-SHEATH, LEAVING THE BASKET AND BASKET PULL-WIRE INSIDE THE PT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BASKET AND BASKET PULL WIRE BY ENLARGING A PREVIOUS SPHINCTEROTOMY WITH UNSPECIFIED BALLOON CATHETERS, HOWEVER, THIS WAS UNSUCCESSFUL. THE PT WAS TAKEN TO THE OPERATING ROOM WHERE THE BASKET AND BASKET PULL WIRE WERE SURGICALLY RETRIEVED. THE PT'S STATUS IS REPORTED AS "RECOVERING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC - LITHOTRIPSY BASKET LQC BOSTON SCIENTIFIC M00510880 0011841706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALLIANCE PRESSURE GUN