BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2101856 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01624
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 2, 2011
    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

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. SCOPE - OLYMPUS 260V. 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 AND THE SHEATH WAS FOUND TO BE BUCKLED IN MULTIPLE AREAS. ADDITIONALLY THE SHEATH WAS TORN AT DISTAL END OF THE HEAT SHRINK. FUNCTIONALLY THE BASKET FAILED TO EXTEND DUE TO THE DAMAGE NOTED TO THE SHEATH AND THE HEAVY RESIDUE. THE BASKET WAS MANUALLY EXTENDED AND RETRACTED AND THE WIRES WERE FOUND TO BE EVEN SPACED AND NOT DEFORMED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BASKET WON'T OPEN AND SHEATH ACCORDIONED. HOWEVER DURING DEVICE EVALUATION IT WAS ALSO NOTED THAT THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE SHEATH WAS TORN. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS ALONG WITH HEAVY CONTRAST RESIDUE LIMITING THE DEVICE PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (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 REMOVAL OF THE BILE DUCT STONES PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO EXTEND. REPORTEDLY THE DEVICE EXTENDED PROPERLY TO CAPTURE/CRUSH STONES MULTIPLE TIMES PRIOR TO THIS. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE OUTER SHEATH WAS ACCORDIONED. NO OTHER DEVICE DAMAGE NOTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDE-CAR PUSH-BACK AND SHEATH TORN.

    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 0013622370

    Patients

    Seq Age Sex Outcome Treatment
    1