BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1698246 · Received May 25, 2010

    Report

    Report Number
    3005099803-2010-02323
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED IN A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE DEVICE WAS SITUATED BEHIND THE STONE AND DEPLOYED WITHOUT ISSUE. HOWEVER, WHEN THE PHYSICIAN WAS READY TO REMOVE THE RETRIEVAL COIL FROM THE PATIENT, THE DEVICE WOULD NOT CLOSE BACK INTO THE SHEATH. "THE COIL WAS JAMMED." THE ACCOUNT STATED THAT IT IS POSSIBLE THAT A STONE WAS IN THE DEVICE, WHICH CAUSED THE PROBLEM. THE PHYSICIAN WAS EVENTUALLY ABLE TO CLOSE THE COIL AND REMOVE IT FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD 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 FINE.

    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 M0063903100 0000633335

    Patients

    Seq Age Sex Outcome Treatment
    1