BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2031399 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01070
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE SUB ASSEMBLY WIRE BASKET REMOVED FROM THE DEVICE AND NO OTHER COMPONENTS WERE RETURNED FOR EVALUATION. THE BASKET WIRES WERE BADLY MISSHAPEN AND BENT AND THE PULL-WIRE SECTION WAS KINKED AND TWISTED. PROXIMAL END OF THE WIRE BASKET ASSEMBLY WAS FRACTURED AND NECKED DOWN AND BROKEN INTO "V" SHAPE INDICATING THAT THE WIRE HAD MOST LIKELY SHEARED APART. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE SAMPLE RETURN CONDITION. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE TIP FAILED TO DETACH AND PULL WIRE BROKE. MICROSCOPIC REVIEW IT WAS DETERMINED THAT THE PULL-WIRE MOST LIKELY HAD SHEARED APART. A MATERIAL REVIEW OF THE BROKEN COMPONENT FOUND NO ANOMALIES AND CONCLUDED THAT THE PULL-WIRE MET THE SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCT: ALLIANCE II HANDLE. OLYMPUS LITHOCRUSH BASKET. 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 A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN CAPTURED A 25MM STONE IN THE MAIN BILIARY DUCT WITH THE TRAPEZOID. WHEN AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE II SYSTEM, THE BASKET WIRE BROKE AT THE LEVEL OF THE HANDLE AND THE BASKET TIP DID NOT DETACH. A SOHENDRA LITHOTRIPSY SYSTEM WAS THEN USED AND THE BASKET WIRE BROKE AT THE MIDDLE, LEAVING THE BASKET WITHIN THE BILIARY DUCT. AN OLYMPUS LITHOCRUSH DEVICE WAS THEN USED TO CRUSH THE STONE AND REMOVE THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET FROM THE PATIENT. REPORTEDLY OTHER STONES WERE CAPTURED AND/OR CRUSHED WITH THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET PRIOR TO THE ALLEGED FAILURE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN CAPTURED A 25MM STONE IN THE MAIN BILIARY DUCT WITH THE TRAPEZOID. WHEN AN ATTEMPT WAS MADE TO CRUSH THE STONE USING THE ALLIANCE II SYSTEM, THE BASKET WIRE BROKE AT THE LEVEL OF THE HANDLE AND THE BASKET TIP DID NOT DETACH. A SOHENDRA LITHOTRIPSY SYSTEM WAS THEN USED AND THE BASKET WIRE BROKE AT THE MIDDLE, LEAVING THE BASKET WITHIN THE BILIARY DUCT. AN OLYMPUS LITHOCRUSH DEVICE WAS THEN USED TO CRUSH THE STONE AND REMOVE THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET FROM THE PATIENT. REPORTEDLY OTHER STONES WERE CAPTURED AND/OR CRUSHED WITH THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET PRIOR TO THE ALLEGED FAILURE. 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 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 M00510890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention