BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLEX?

    MDR report key: 3053378 · Received April 11, 2013

    Report

    Report Number
    3005099803-2013-02461
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED OPTIFLEX RETRIEVAL BASKET REVEALED THE INTRODUCER WAS ON THE SHEATH. THE BASKET WAS OPEN EXTENDING APPROXIMATELY 3CM FROM THE DISTAL END OF THE SHEATH. THE BASKET AND ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED; ONE OF THE BASKET WIRES WAS BROKEN AT THE DISTAL END AND TWO WERE BENT. NO ISSUES WERE IDENTIFIED WITH THE SHEATH. WHEN THE THUMBWHEEL WAS ACTUATED, THE BASKET WOULD NOT CLOSE. THE PINCH VISE WOULD TURN FREELY, AND THE BASKET WOULD NOT ROTATE. THE HANDLE WAS DISASSEMBLED AND THE BASKET PULL WIRE WAS BROKEN AT THE PROXIMAL END AT THE PINCH VISE. THE BASKET OPENED AND CLOSED WITHOUT ISSUE WHEN USING THE BASKET WIRE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT IT SHOULD ALSO BE NOTED THAT THE DEFECTS FOUND DURING EVALUATION OF THE RETURNED DEVICE DO NOT CONSTITUTE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 STATED THAT THE BASKET HAD A BROKEN BASKET WIRE THAT REMAINED ATTACHED TO THE DEVICE AT ONE END.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN OPTIFLEX RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER SUCCESSFULLY REMOVING SEVERAL STONE FRAGMENTS, THE BASKET WOULD NOT OPEN AND CLOSE EASILY. IT IS UNKNOWN IF THERE WAS A STONE IN THE BASKET WHEN THE EVENT OCCURRED OR IF IT HAPPENED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN OPTIFLEX RETRIEVAL BASKET. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER SUCCESSFULLY REMOVING SEVERAL STONE FRAGMENTS, THE BASKET WOULD NOT OPEN AND CLOSE EASILY. IT IS UNKNOWN IF THERE WAS A STONE IN THE BASKET WHEN THE EVENT OCCURRED OR IF IT HAPPENED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156554 OPTIFLEX? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063903010 15868950

    Patients

    Seq Age Sex Outcome Treatment
    1