BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLEX NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1516718 · Received October 14, 2009

    Report

    Report Number
    3005099803-2009-04834
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    August 12, 2009
    Report Date
    October 1, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS FOUND THE BASKET WAS CLOSED AND COULD NOT BE OPENED DUE TO THE THUMB WHEEL NOT MOVING. A "CLEAR/TRANSLUCENT, GUMMY MATERIAL" WAS FOUND ON THE INTERIOR OF THE SHEATH. THE MATERIAL DID NOT PREVENT MANUAL FUNCTION OF THE RETRIEVAL BASKET. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THE EVALUATION RESULTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN OPTIFLEX NITINOL STONE RETRIEVAL BASKET WAS USED FOR A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, THE RETRIEVAL BASKET WOULD NOT OPEN OR CLOSE OUTSIDE THE PT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX NITINOL STONE RETRIEVAL BASKET FFL BOSTON SCIENTIFIC CORP M0063903010 12752178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK