BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL INDWELLING CATHETER/STENT

    MDR report key: 2001406 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00601
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS PLACED IN A PATIENT (AGE, SEX, WEIGHT UNKNOWN) ON AN UNKNOWN PROCEDURE DATE. ACCORDING TO THE COMPLAINANT, THE STENT BECAME BLOCKED WHEN PLACED DUE TO COMPRESSION FROM TUMOR. THE STENT WAS PLACED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL INDWELLING CATHETER/STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M0061802220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other