BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 3233600 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-07325
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DETAILED INSPECTION AND ANALYSIS WA PERFORMED ON THE RETURNED STONE CONE NITINOL RETRIEVAL COIL. IT WAS OBSERVED THAT THE WHITE HEAT SHRINK HAD BEEN TORN INTO TWO PIECES AND ACCORDIONED, EXPOSING THE COREWIRE. THERE WAS A KINK IN THE BLUE SHEATH FROM THE DISTAL END. THE DEVICE WAS ABLE TO OPEN FREELY, BUT COULD NOT CLOSE COMPLETELY. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED. AND NO ISSUES WERE IDENTIFIED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THEREFORE THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED DURING A URETERAL STONE LITHOTRIPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THEY TESTED THE DEVICE FOR FUNCTIONALITY, THE DEVICE WOULD OPEN HOWEVER, IT WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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
    335698 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO ACCELLENT ENDOSCOPY JUAREZ M0063903200 A51721

    Patients

    Seq Age Sex Outcome Treatment
    1