BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 4092554 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03102
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE INDICATING USE/HANDLING AND THE BASKET WAS FOUND TO BE FULLY RETRACTED. THE SIDE CAR-RX PRESENTS PUSHBACK. EVALUATION SHOWS THE BASKET WAS UNABLE TO EXTEND DUE TO DRIED RESIDUE INSIDE THE DEVICE. THE SIDE CAR-RX PUSHBACK COULD CAUSE DIFFICULTY IN TRACKING THE DEVICE OVER THE GUIDEWIRE AND INTO THE PAPILLA. PER THE EVENT INFORMATION THE ISSUE OCCURRED WHILE INSIDE THE PATIENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF 'OPERATIONAL CONTEXT' IS SELECTED FOR THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF SIDE CAR - RX PUSHBACK. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX TRAPEZOID LITHOTRIPTER COMPATABLE BASKET WAS USED IN THE COMMON BILE DUCT DURING A BILIARY LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT THE LITHOTRIPTER DEVICE INTO THE PAPILLA AND BILE DUCT ALONG THE GUIDE WIRE BUT THE SIDCAR RX OF THE DEVICE WAS NOTED TO BE PUSHED BACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 ¿GOOD.¿

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX TRAPEZOID LITHOTRIPTER COMPATABLE BASKET WAS USED IN THE COMMON BILE DUCT DURING A BILIARY LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT THE LITHOTRIPTER DEVICE INTO THE PAPILLA AND BILE DUCT ALONG THE GUIDE WIRE BUT THE SIDCAR RX OF THE DEVICE WAS NOTED TO BE PUSHED BACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 ¿GOOD¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572553 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 16594453

    Patients

    Seq Age Sex Outcome Treatment
    1