BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 1585722 · Received January 20, 2010

    Report

    Report Number
    3005099803-2010-00188
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ACCELLENT ENDOSCOPY JUAREZ
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE SHEATH DID NOT SEPARATE FROM THE HANDLE HUB AND NO OTHER PORTION OF THE SHEATH WAS NOTICED TO BE DAMAGED. IT IS UNKNOWN IF THE WIRE AND/OR COIL WAS DAMAGED. NO STONE WAS PRESENT IN THE DEVICE WHEN THE MALFUNCTION OCCURRED, AND THE SURGEON WAS ABLE TO WITHDRAW THE DEVICE FROM THE PATIENT WITHOUT AN ADDITIONAL RETRIEVAL DEVICE. THE DEVICE WAS NOT REUSED OR REPROCESSED, AND WAS USED FOR TREATMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN, HOWEVER THE FAILURE OF THE STONE CONE HAS NOT AFFECTED THE PATIENT'S PROGNOSIS."

    Additional Manufacturer Narrative · 1

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. 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 INFO RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED FOR A RIGID URETEROSCOPY AND EXTRACTION OF CALCULUS PROCEDURE PERFORMED ON (B)(6), 2009 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN.) ACCORDING TO THE COMPLAINANT, THE RETRIEVAL COIL WIRE AND SHEATH "SEPARATED ON INITIAL DEPLOYMENT." CONSEQUENTLY, THERE WAS DIFFICULTY CLOSING THE RETRIEVAL COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6), 2010 THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS USED FOR A RIGID URETEROSCOPY AND EXTRACTION OF CALCULUS PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, THE RETRIEVAL COIL WIRE AND SHEATH "SEPARATED ON INITIAL DEPLOYMENT." CONSEQUENTLY, THERE WAS DIFFICULTY CLOSING THE RETRIEVAL COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PT AND EVENT INFO. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    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 0000641779

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK