BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1081446 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01284
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW OF THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A COATING DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE LEFT KIDNEY. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, SOME OF THE STONE CONE 3FR./7MM RETRIEVAL COIL COATING "CAME OFF IN THE KIDNEY". THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PORTION WITH AN UNSPECIFIED GRASPER. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT'S STATUS IS REPORTED AS "FINE". IT WAS FURTHER NOTED THAT THE PROCEDURE TOOK AN ADDITIONAL 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL FGO - DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC M0063903100 0000605993

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention