BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088

    MDR report key: 2223415 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02776
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND RESIDUE ON THE DEVICE INDICATING PROCEDURAL USE AND THE BASKET WAS IN THE CLOSED POSITION. THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY EXTENDING AND RETRACTING THE DEVICE MULTIPLE TIMES. THE BASKET DID NOT FULLY OPEN AS THE BASKET WIRES WERE FOUND TO BE FOLDED OVER AND TWISTED AT PROXIMAL AND DISTAL ENDS OF THE BASKET. THE BASKET WAS MANUALLY UNTWISTED AND FOUND TO BE PROPERLY FORMED. THE DEVICE WAS THEN AGAIN FUNCTIONED AND THE BASKET FULLY EXTENDED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET WIRES WERE TWISTED AND IT WOULD NOT EXTEND FULLY. HOWEVER, DURING DEVICE EVALUATION, IT WAS ALSO NOTED THAT THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT ALL ACCEPTED DEVICES MET THE MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A BILIARY STONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE CASE, THE DEVICE WAS INSPECTED AND THE BASKET WIRES WERE FOUND TO BE TWISTED AND COILED. ADDITIONALLY, THE BASKET WOULD NOT FULLY EXTEND DUE TO THE TWISTED WIRES. THE DEVICE WAS ADVANCED INTO THE PATIENT, BUT FOUND TO NOT OPEN ENOUGH TO PERFORM THE STONE LITHOTRIPSY. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. REPORTEDLY, NO OTHER DEVICE DAMAGE WAS VISIBLE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDE-CAR PUSH-BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 LITHOTRIPTOR, BILIARY MECHANICAL LQC BOSTON SCIENTIFIC - SPENCER M00510890 14251815

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR