BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 1904567 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04864
    Event Type
    Injury
    Date Received
    November 22, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PERCUFLEX PLUS URETERAL STENT REVEALED SIGNIFICANT CALCIFIED DEPOSITS ON THE STENT OUTER DIAMETER. A 0.038" GUIDEWIRE COULD NOT BE PASSED THROUGH THE STENT INNER DIAMETER. BASED ON THE ANALYSIS, IT HAS BEEN DETERMINED THAT THE STENT WAS OCCLUDED DUE TO CALCIFIED DEPOSITS. CATHETER OCCLUSION IS INDICATED IN THE DFU AS A POTENTIAL COMPLICATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT "THE PATIENT IMPLANTED WITH THIS STENT SHOWED A HYDRONEPHROSIS." MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT "THE PATIENT IMPLANTED WITH THIS STENT SHOWED A HYDRONEPHROSIS." MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M0061752620 0013485444

    Patients

    Seq Age Sex Outcome Treatment
    1 Other