BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR VL?

    MDR report key: 3231296 · Received July 17, 2013

    Report

    Report Number
    3005099803-2013-06628
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL URETERAL STENT WAS IMPLANTED AROUND (B)(6) 2012 DURING A PYELOSCOPY PROCEDURE WAS PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013 DURING A STENT REMOVAL PROCEDURE, THE HEAVILY ENCRUSTED STENT BROKE UPON TRYING TO REMOVE IT. THE STENT WAS LEFT INSIDE THE PATIENT AND THE PATIENT WAS SCHEDULED FOR ANOTHER PYELSOCOPY PROCEDURE ON (B)(6) 2013, WHEREIN THE BROKEN ENCRUSTED STENT WAS SUCCESSFULLY REMOVED USING TRICEP BASKET AND SEGURA BASKET. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331556 CONTOUR VL? STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006180156170 15983558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention