BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2152023 · Received July 7, 2011

    Report

    Report Number
    3005099803-2011-02319
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND THE BASKET TO BE EXTENDED. THE THUMB RING WAS BROKEN OFF AND NOT RETURNED. ADDITIONALLY, THE SIDECAR RX PRESENTED PUSHBACK AND THE COIL ASSEMBLY WAS FOUND TO BE BUCKLED IN MULTIPLE PLACES. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING THE BASKET USING THE FINGER RING AND SOME RESISTANCE WAS NOTED. THE BASKET WAS FULLY EXTENDED AND THE BASKET WIRES WERE FOUND TO BE BENT AND UNEVENLY SPACED. THE TIP WAS FOUND TO BE INTACT AND UNDEFORMED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET TIP DID NOT DETACH. A MATERIAL REVIEW OF THE SUB ASSEMBLY BASKET COMPONENT FOUND NO ANOMALIES AND CONCLUDED THAT THE BASKET TIP MET THE SPECIFICATIONS. THE DEVICE IS DESIGNED SO THAT THE BASKET TIP DETACHES IF THE STONE CANNOT BE CRUSHED, HOWEVER, FROM THE ANALYSIS OF THE RETURNED DEVICE THIS DID NOT OCCUR. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE PATIENT ID AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 1

    (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, STONES WERE EXTRACTED FROM THE COMMON BILE DUCT WITH A BALLOON. CONTRAST WAS USED AND BIGGER STONES WERE NOTED. THE PHYSICIAN ATTEMPTED TO USE THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET TO REMOVE THE STONES. A STONE WAS CAPTURED WITHIN THE BASKET AND THE PHYSICIAN TRIED TO PULL THE STONE FROM THE COMMON BILE DUCT, HOWEVER THE STONE WAS TOO BIG. AN ATTEMPT TO CRUSH THE STONE WAS MADE, HOWEVER THE BASKET WOULD NOT CRUSH THE STONE AND THE TIP FAILED TO DETACH. THE PHYSICIAN STRUGGLED TO REMOVE THE STONE FROM THE BASKET FOR APPROXIMATELY 10 MINUTES. THE PHYSICIAN WAS ABLE TO RELEASE THE STONE AND THE BASKET WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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

    ADDITIONAL INFORMATION: THE SIZE OF THE STONE WAS 1.5CM TO 2CM.

    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, STONES WERE EXTRACTED FROM THE COMMON BILE DUCT WITH A BALLOON. CONTRAST WAS USED AND BIGGER STONES WERE NOTED. THE PHYSICIAN ATTEMPTED TO USE THE TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET TO REMOVE THE STONES. A STONE WAS CAPTURED WITHIN THE BASKET AND THE PHYSICIAN TRIED TO PULL THE STONE FROM THE COMMON BILE DUCT, HOWEVER THE STONE WAS TOO BIG. AN ATTEMPT TO CRUSH THE STONE WAS MADE, HOWEVER THE BASKET WOULD NOT CRUSH THE STONE AND THE TIP FAILED TO DETACH. THE PHYSICIAN STRUGGLED TO REMOVE THE STONE FROM THE BASKET FOR APPROXIMATELY 10 MINUTES. THE PHYSICIAN WAS ABLE TO RELEASE THE STONE AND THE BASKET WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 13680700

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR