BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1945937 · Received January 4, 2011

    Report

    Report Number
    3005099803-2010-05250
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE PROXIMAL END SHEATH WAS FOUND TO BE BUCKLED. THE SIDE-CAR PRESENTED PUSH-BACK AND A SLIGHT TEAR. FUNCTIONALLY, A GUIDEWIRE WAS PUT THROUGH THE SIDE-CAR AND THE DEVICE WAS INSERTED INTO A SCOPE AND IT EASILY EXITED WITHOUT DIFFICULTY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT, AS THE DEVICE WAS ABLE TO BE INSERTED AND EXITED THROUGH A SAMPLE SCOPE WITHOUT DIFFICULTY. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE CONFIRMED, HOWEVER DURING EVALUATION IT WAS NOTED THAT THE SIDE-CAR HAD A TEAR AND PRESENTED PUSH-BACK AND THE COIL ASSEMBLY WAS BUCKLED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGES IS CONSIDERED 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 INITIALLY 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), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WOULD NOT ADVANCE FROM THE DISTAL END OF THE SCOPE. IT WAS REPORTED THAT THE ELEVATOR ON THE SCOPE WAS IN THE DOWN POSITION AT THE TIME OF THIS EVENT. THE DEVICE WAS REMOVED FROM THE SCOPE WITHOUT REMOVING THE SCOPE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. THERE WAS NO REPORT OF DAMAGE TO THE SCOPE. 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SIDE-CAR TORN AND 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 M00510880 0013666086

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR