BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1990188 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00396
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL AND LOT NUMBER; THEREFORE, THE PRODUCT DETAILS, LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - NO CODE AVAILABLE (INTERVENTION REQUIRED TO REMOVE DEVICE). (B)(4), NO CODE AVAILABLE (TIP WON'T DETACH). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF WIRE BREAK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STONE WAS TOO LARGE (APPROXIMATELY 20MM) AND TOO HARD TO BE REMOVED OR CRUSHED. AN ATTEMPT WAS MADE TO DETACH THE TIP OF THE BASKET TO REMOVE THE DEVICE BUT THE WIRE BROKE WITHIN THE HANDLE WHILE THE BASKET WAS WITHIN THE BILE DUCT. THE BASKET DID NOT DETACH INTO THE PATIENT. REPORTEDLY, IT WAS NOT POSSIBLE TO PERFORM AN EMERGENCY LITHOTRIPSY SINCE THE SYSTEM DID NOT WORK, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE ESWL (EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY) WAS PERFORMED TO CRUSH THE STONE AND REMOVE THE BASKET. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    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 UNK213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention