BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID¿ RX

    MDR report key: 2332432 · Received November 10, 2011

    Report

    Report Number
    3005099803-2011-03925
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 20, 2011
    Report Date
    October 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE LUMEN (SIDECAR) PRESENTED PUSH-BACK. THE BASKET RETURNED IN THE CLOSED POSITION WITH THE BASKET TIP INTACT. FUNCTIONALLY, THE BASKET EXTENDED AND RETRACTED WITHOUT ISSUE. WHEN EXTENDED, THE BASKET WIRES WERE FOUND TO BE EVENLY SPACED AND PROPERLY FORMED. A SECOND FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY INSERTING A .035 INCH GUIDEWIRE THROUGH THE SIDECAR RX WITHOUT ISSUE THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE GUIDEWIRE LUMEN (SIDECAR) PRESENTED PUSHBACK. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE INTEGRITY. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT DUE TO ANATOMICAL OR PROCEDURAL FACTORS AFFECTING THE INTEGRITY OF THE DEVICE AND LIMITING THE DEVICE PERFORMANCE. 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.

    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, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE BASKET DEVICE IN THE PATIENT. REPORTEDLY, SIDECAR PUSHBACK WAS PRESENT WHICH ALLOWED THE END OF THE CATHETER TO MOVE IRRESPECTIVE OF THE GUIDEWIRE. NO ADDITIONAL DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A RETRIEVAL BALLOON. 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 OKAY.

    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, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE BASKET DEVICE IN THE PATIENT. REPORTEDLY, SIDECAR PUSHBACK WAS PRESENT WHICH ALLOWED THE END OF THE CATHETER TO MOVE IRRESPECTIVE OF THE GUIDEWIRE. NO ADDITIONAL DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A RETRIEVAL BALLOON. 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID¿ RX LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510880 14222368

    Patients

    Seq Age Sex Outcome Treatment
    1