BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCERTA¿

    MDR report key: 6176801 · Received December 15, 2016

    Report

    Report Number
    3005099803-2016-03906
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ASCERTA¿ URETERAL STENT WAS IMPLANTED IN THE LEFT URETER ON (B)(6) 2016 AND WAS WITHDRAWN DURING STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE STENT WAS DIFFICULTY TO WITHDRAW DURING STENT REMOVAL. A GRASPER WAS USED TO SUCCESSFULLY REMOVE THE STENT FROM THE PATIENT. THE STENT WAS FOUND STRETCHED AND ELONGATED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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
    829505 ASCERTA¿ STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061456150

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR