BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1664630 · Received April 22, 2010

    Report

    Report Number
    3005099803-2010-01830
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    February 19, 2010
    Report Date
    April 12, 2010
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS REPORTED TO BE OVER 18 YEARS OLD. THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(6). EVALUATION OF THE RETURNED DEVICE INDICATES THE BLUE SHEATH WAS KINKED AND FISH HOOKED IN SEVERAL PLACES ALONG THE DISTAL END OF THE DEVICE, AND TEARING WAS OBSERVED ALONG THE WHITE HEAT SHRINK. THE DISTAL STOP WAS JAMMED INSIDE THE BLUE SHEATH, AND THE DEVICE WAS NOT ABLE TO BE OPENED. ADDITIONALLY, AN ACCORDION DEFECT WAS OBSERVED AT THE DISTAL TIP REVEALING A PORTION OF THE CORE WIRE. NO ANATOMICAL OR PROCEDURAL FACTORS WERE NOTED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS UNDETERMINABLE.

    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 CORPORATION ON FEBRUARY 24, 2010 THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN A "REMOVAL OF THE BILE DUCT STONES" PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS UNABLE TO OPEN AND CLOSE INSIDE THE PATIENT'S URETER. NO STONE WAS IN THE DEVICE WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL. 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 "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO ACCELLENT ENDOSCOPY JUAREZ M0063903200

    Patients

    Seq Age Sex Outcome Treatment
    1