BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1832624 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03977
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ALLIANCE II HANDLE, OLYMPUS LITHOTRIPTER, RX EXTRACTOR BALLOON. (B)(4). TIP WON'T DETACH. 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), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 2.2CM STONE WITHIN THE PATIENT'S COMMON BILE DUCT WAS GRASPED USING THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET. AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE II HANDLE, BUT THE STONE WOULD NOT CRUSH NOR WOULD THE TIP POP OFF THE END OF THE BASKET. REPORTEDLY, THE RX LITHOTRIPTER BASKET WAS CUT AND AN OLYMPUS LITHOTRIPTER WAS INSERTED AND USED TO CRUSH THE STONE THAT WAS WITHIN THE TRAPEZOID RX LITHOTRIPTER BASKET. SOME STONE FRAGMENTS WERE REMOVED WITH THE BASKETS AND AFTERWARDS AN RX EXTRACTOR BALLOON WAS USED TO REMOVE THE REMAINING STONE FRAGMENTS. AN RX BILIARY STENT WAS THEN TEMPORARILY PLACED WITHIN THE COMMON BILE DUCT FOR DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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 M00510890 13502099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention