BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID? RX

    MDR report key: 4469163 · Received January 30, 2015

    Report

    Report Number
    3005099803-2015-00087
    Event Type
    Malfunction
    Date Received
    January 30, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 6, 2015
    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 THE BASKET TO BE FULLY RETRACTED AND THE SIDE CAR-RX PRESENTED PUSHBACK OUT OF SPECIFICATION. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING THE BASKET AND THE BASKET WIRES WERE FOUND TO BE FOLDED. DURING THE EVALUATION THE WIRES WERE MANUALLY UNFOLDED AND THE WIRES WERE FOUND TO BE EVENLY SPACED AND UN-DEFORMED. THE EVALUATION CONCLUDED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PRESENTED SIDE CAR-RX PUSHBACK. THE SIDE CAR-RX PUSHBACK COULD CAUSE DIFFICULTY IN TRACKING THE DEVICE OVER THE GUIDEWIRE AND INTO THE PAPILLA. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS ¿HANDLING DAMAGE.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4) 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 BILE DUCT DURING A STONE REMOVAL PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THEY NOTICED THAT THE LENGTH OF THE BASKET TIP WAS LONGER THAN USUAL. ATTEMPTS TO RETRACT THE BASKET BACK INTO THE SHEATH FAILED. 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 BILE DUCT DURING A STONE REMOVAL PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THEY NOTICED THAT THE LENGTH OF THE BASKET TIP WAS LONGER THAN USUAL. ATTEMPTS TO RETRACT THE BASKET BACK INTO THE SHEATH FAILED. 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
    72907 TRAPEZOID? RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 17395604

    Patients

    Seq Age Sex Outcome Treatment
    1