BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2143146 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02138
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 21, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION IDENTIFIED RESIDUE ON THE RETURNED DEVICE WHICH IS INDICATIVE OF PROCEDURAL USE. ADDITIONALLY, THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK, THE COIL ASSEMBLY WAS BENT AND THE SHEATH WAS FOUND TO BE BUCKLED IN MULTIPLE AREAS AND TORN AT THE HEAT SHRINK DISTAL END. THE BASKET RETURNED IN THE CLOSED POSITION AND FAILED TO FUNCTION. THE BASKET WAS THEN MANUALLY ACTUATED. WHEN EXTENDED, THE WIRES WERE FOUND TO BE TWISTED AND INVERTED. A JAGWIRE WAS ABLE TO BE ADVANCED THROUGH THE SIDECAR RX WITHOUT ISSUE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WOULD NOT OPEN. HOWEVER, THE EVALUATION ALSO FOUND THAT THE GUIDEWIRE LUMEN (SIDE-CAR) PRESENTED PUSH-BACK AND THE SHEATH WAS TORN. THE DEVICE IS INSPECTED FOR BASKET EXTENSION AND RETRACTION AND ALSO FOR SHEATH COSMETICS DURING ASSEMBLY AND PRIOR TO PACKAGING SO THE DAMAGE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE DEVICE INTO THE BILE DUCT, THE BASKET WAS NOT ABLE TO BE EXTENDED. THE USER REPORTED THAT THE BASKET EXTENSION WAS TESTED PRIOR TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET. 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 PUSHBACK 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 13408420

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR