BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 2040845 · Received March 23, 2011

    Report

    Report Number
    3001845648-2011-00012
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICES OF LOT # C529234 IN STOCK AT THE TIME COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL; THEREFORE, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE, THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. THE INFO PROVIDED FOR THIS COMPLAINT INDICATED THAT THE STENT INVOLVED IN THIS COMPLAINT HAD TO BE REMOVED AFTER 2 MONTHS BECAUSE OF INFECTION AND STENT WAS CRYSTALLIZED. IT IS UNK IF THIS INFECTION WAS PRESENT PRIOR TO INSERTION OF THE STENTS, THEREFORE, IT CANNOT BE CONFIRMED THAT THIS WAS CAUSED BY THE RESONANCE STENT. IT MAY BE NOTED THAT NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PT REQUIRED AN ADD'L PROCEDURE DUE TO THIS OCCURRENCE WHICH WAS THAT ANOTHER STENT HAD TO BE PLACED. PRIOR TO DISTRIBUTION, ALL RESONANCE DEVICES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR LOT #C529234 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. RESONANCE DEVICES ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. THESE DEVICES ARE INTENDED FOR ONE-TIME USE. A 2 YEAR REVIEW OF THE COMPLAINTS HISTORY REVEALED NO OTHER COMPLAINTS IN RELATION TO THIS COMPLAINT ISSUE. THEREFORE, THIS IS CONSIDERED AN ISOLATED INCIDENT AND IS UNLIKELY TO RECUR. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME HOWEVER, CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    STENT HAD TO BE REMOVED AFTER 2 MONTHS BECAUSE OF INFECTION AND STENT WAS CRYSTALLIZED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PT DID REQUIRE ADD'L PROCEDURES DUE TO THIS OCCURRENCE. THE PRODUCT DID CAUSE OR CONTRIBUTE TO THE NEED FOR ADD'L PROCEDURES. THE ADD'L PROCEDURES WERE ANOTHER STENT HAD TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD C529234

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention