BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 2103432 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01714
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON (B)(6), 2011 STATING STONE CONE NITINOL RETRIEVAL BASKET TIP WAS REMOVED FROM THE PATIENT VIA A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(6), 2011. THE PATIENT WAS REPORTED TO BE "FIT AND WELL". THE FACILITY REPORTED THAT THE TIP FRAGMENT WILL BE RETURNED UPON COMPLETION OF HOSPITAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE RETRIEVAL DEVICE WAS USED IN A FLEXIBLE UTEROSCOPY PROCEDURE (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN DEPLOYED THE STONE CONE BEHIND THE STONE AND WAS LASERING THE UPPER STONE WHEN A SECTION OF THE STONE CONE SPIRAL TIP BROKE OFF AND FELL INTO THE RENAL PELVIS. PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN SECTION WITH GRASPING FORCEPS. ADDITIONAL SURGERY MAY BE REQUIRED DEPENDING ON THE RESULTS OF A CT SCAN. AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. THE PATIENT IS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE RETRIEVAL DEVICE WAS USED IN A FLEXIBLE UTEROSCOPY PROCEDURE (PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN DEPLOYED THE STONE CONE BEHIND THE STONE AND WAS LASERING THE UPPER STONE WHEN A SECTION OF THE STONE CONE SPIRAL TIP BROKE OFF AND FELL INTO THE RENAL PELVIS. PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN SECTION WITH GRASPING FORCEPS. ADDITIONAL SURGERY MAY BE REQUIRED DEPENDING ON THE RESULTS OF A CT SCAN. AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. THE PATIENT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903100 0000709961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention