BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 5987295 · Received September 29, 2016

    Report

    Report Number
    3005099803-2016-02848
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 5, 2016
    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 EVALUATION OF THE RETURNED DEVICE FOUND THE SIDE CAR-RX PRESENTED PUSHBACK OUT OF SPECIFICATION AND WAS BUCKLED FROM THE DISTAL END. FUNCTIONAL EVALUATION FOUND THE BASKET WOULD EASILY EXTEND AND RETRACT. THE BASKET WIRES WERE EVENLY SPACED AND UN-DEFORMED. THE EVALUATION CONCLUDED THAT DURING THE PROCEDURE MANIPULATION OF THE DEVICE AND INTERACTION WITH THE SCOPE OR OTHER DEVICES MOST LIKELY CONTRIBUTED TO THE SIDE CAR PUSHBACK. DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE FOUND. A SEARCH OF THE DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). 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 A TRAPEZOID RX BASKET WAS USED IN THE COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN EXPERIENCE DIFFICULTY IN OPENING THE BASKET AND WAS NO LONGER ABLE TO OPENED EVEN WHEN THE HANDLE WAS ACTUATED FORCEFULLY. MOREOVER, THE SIDE CAR-RX (GUIDEWIRE PORT) WAS FOUND TORN AND PUSHBACK. 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 A TRAPEZOID(TM) RX BASKET WAS USED IN THE COMMON BILE DUCT DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN EXPERIENCE DIFFICULTY IN OPENING THE BASKET AND WAS NO LONGER ABLE TO OPENED EVEN WHEN THE HANDLE WAS ACTUATED FORCEFULLY. MOREOVER, THE SIDE CAR-RX (GUIDEWIRE PORT) WAS FOUND TORN AND PUSHBACK. 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
    640027 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 19424534

    Patients

    Seq Age Sex Outcome Treatment
    1