BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2855140 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05548
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, PROCEDURE PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, SPYGLASS, EHL (ELECTROHYDRAULIC LITHOTRIPSY) AND A RX LITHOTRIPTER COMPATIBLE BASKET WERE USED IN AN ERCP PROCEDURE WITHIN THE COMMON BILE DUCT. THE PROCEDURE WAS CONSIDERED A "VERY DIFFICULT STONE CASE", AND WHEN LITHOTRIPSY WAS ATTEMPTED WITH THE RX LITHOTRIPTER COMPATIBLE BASKET IN CONJUNCTION WITH THE ALLIANCE HANDLE ON A VERY LARGE STONE, THE STONE WAS UNABLE TO BE CRUSHED AND THE HANDLE OF THE BASKET BROKE. CONSEQUENTLY THEY WERE UNABLE TO OPERATE THE BASKET, AND THE BASKET BECAME STUCK AROUND THE STONE. THE HANDLE WAS CUT FROM THE WORKING LENGTH OF THE BASKET. THE WORKING LENGTH AND THE BASKET REMAINED INSIDE THE PATIENT. A SOEHENDRA DEVICE WAS THEN USED IN AN ATTEMPT TO CRUSH THE STONE AND DETACH THE TIP OF THE BASKET, HOWEVER THE TIP FAILED TO DETACH AND THE STONE WAS UNABLE TO BE CRUSHED. APC WAS THEN USED TO BURN THE WORKING LENGTH WIRE WHERE THE WORKING LENGTH MEETS THE BASKET. THE WORKING LENGTH WAS REMOVED AND THE BASKET AND STONE WERE LEFT INSIDE THE PATIENT. STENTS WERE PLACED FOR DRAINAGE AND THE CASE WAS ENDED. THERE WERE NO COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT WAS SENT HOME AND IS SCHEDULED FOR ANOTHER ERCP IN ORDER TO REMOVE THE BASKET AND THE STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 15340612

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention