BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX? PLUS

    MDR report key: 3792263 · Received May 6, 2014

    Report

    Report Number
    3005099803-2014-01834
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF STENT WAS DIFFICULT TO REMOVE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) AND WAS EXPLANTED DURING STENT REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING STENT REMOVAL, THE STENT WAS DIFFICULT TO BE REMOVED AND WAS FURTHER INVESTIGATED TO HAVE SEVERAL KINKS. THE PHYSICIAN CUT THE STENT WITH A LASER TO REMOVE THE STENT SAFELY. IT WAS ADDED THAT THE STENT WAS NOT ENCRUSTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272259 PERCUFLEX? PLUS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006175253090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention