BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLEX?

    MDR report key: 3052111 · Received April 11, 2013

    Report

    Report Number
    3005099803-2013-02456
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 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 AND THE BASKET WAS CLOSED. THE SHEATH WAS DETACHED FROM THE RACK GEAR WHEN RECEIVED, BUT REMAINED ON THE BASKET PULL WIRE. THE SHEATH WAS BENT IN SEVERAL LOCATIONS ALONG THE WORKING LENGTH. WHEN THE THUMBWHEEL WAS ACTUATED, THE BASKET WOULD NOT OPEN; THE THUMBWHEEL WOULD NOT MOVE FREELY. THE PINCH VISE WOULD TURN FREELY. THE HANDLE WAS DISASSEMBLED AND THE GLUE PLUG WAS NOT DETACHED FROM THE RACK GEAR. THE SHEATH DETACHED APPROXIMATELY .5MM FROM THE DISTAL END OF THE RACK GEAR. THE BASKET WIRE WAS REMOVED FROM THE DETACHED SHEATH; THE WIRE MOVED FREELY THROUGH THE SHEATH DURING REMOVAL. THE BASKET AND ALL OF THE BASKET WIRES WERE PRESENT AND ATTACHED; ONE OF THE BASKET WIRES WAS DETACHED AT THE DISTAL END. 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. REVIEW OF THE RETURNED DEVICE AND ALL AVAILABLE INFORMATION FAILED TO IDENTIFY A MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT, AND IS THEREFORE, UNDETERMINABLE.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AN OPTIFLEX RETRIEVAL BASKET USED DURING A PROCEDURE ON (B)(4) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BASKET WOULD NOT OPEN AND CLOSE EASILY. IT IS UNKNOWN IF THERE WAS A STONE IN THE BASKET WHEN THE EVENT OCCURRED OR HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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 USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BASKET WOULD NOT OPEN AND CLOSE EASILY. IT IS UNKNOWN IF THERE WAS A STONE IN THE BASKET WHEN THE EVENT OCCURRED OR HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154713 OPTIFLEX? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063903010 15868950

    Patients

    Seq Age Sex Outcome Treatment
    1