BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 4143541 · Received October 6, 2014

    Report

    Report Number
    1118880-2014-00031
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K954234
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS - IS BASED UPON EVALUATION OF RETURNED SAMPLE AND USER FACILITY INFORMATION; IS BASED UPON TESTING OF RESERVE SAMPLES. CONCLUSIONS - IS BASED UPON EVALUATION OF RETURNED SAMPLE; IS BASED UPON TESTING OF RESERVE SAMPLES. THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS. LEAKAGE WAS NOTED COMING FROM UNDER THE SHEATH SUPPORT WHEN THE SHEATH WAS FLUSHED WITH BLEACH SOLUTION DURING DECONTAMINATION. MAGNIFICATION INSPECTION OF THE SHEATH DID NOT REVEAL ANY DEFECTS. THE SHEATH SUPPORT WAS REMOVED AND TWO SMALL CRACKS IN THE SHEATH WERE NOTED. THE SHEATH WAS ALSO NOTED TO BE SLIGHTLY DEFORMED IN THIS AREA. THE USER FACILITY COULD NOT PROVIDE THE LOT NUMBER DEFINITIVELY, BUT BELIEVED THAT IT MAY HAVE BEEN QM30. THEREFORE, AN EVALUATION OF THE RETENTION SAMPLE FROM RSS604/QM30, AND THE SURROUNDING LOTS MANUFACTURED WAS CONDUCTED. A VISUAL EXAMINATION OF THE SAMPLES CONFIRMED THERE WERE NO VISUAL DEFECTS. LEAKAGE TESTING REVEALED NO LEAKAGE OF THE DEVICES. THE PRODUCTION LOT NUMBER COULD NOT BE CONFIRMED BY THE USER FACILITY, WHICH PREVENTED REVIEW OF APPLICABLE PRODUCTION AND COMPLAINT RECORDS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, BASED ON THE AVAILABLE INFORMATION THE APPEARANCE OF THE INVOLVED SAMPLE, IT IS LIKELY THAT THE SHEATH MAY HAVE BEEN DAMAGED WHEN ANOTHER DEVICE WAS ADVANCED THROUGH THE SHEATH RESULTING IN THE REPORTED ISSUE. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A CRACK IN THE WALL OF THE SHEATH DURING A CEREBRAL COILING PROCEDURE. FOLLOW-UP COMMUNICATION FROM THE USER FACILITY REPORTED: ACCESS WAS GAINED WITH A 6FR PINNACLE SHEATH BEING INTRODUCED INTO THE FEMORAL ARTERY; AFTER INSERTION IT APPEARED THAT A HEMATOMA WAS FORMING AT THE ACCESS SITE; THE IR APPLIED DIRECT PRESSURE FOR A FEW MINUTES AND IT SEEMED THAT THE BLEEDING STOPPED; THE SHEATH WAS SUTURED TO THE PATIENT AND STUCK DOWN WITH A TEGADERM; A BLOOD/FLUID SOLUTION WAS THEN SEEN RUNNING ALONG THE SIDE TUBE UNDER THE TAGADERM; WHEN THEY WENT TO MOVE THE PATIENT IT WAS NOTICED THAT A LARGE AMOUNT OF DILUTED BLOOD WAS UNDER THE PATIENT; AT THIS POINT THE PHYSICIAN DID A CONTRAST RUN DIRECTLY THROUGH THE SIDE TUBE OF THE SHEATH AND FELT THAT THE CONTRAST WAS LEAKING OUT PRIOR TO THE TIP OF THE SHEATH; THE PINNACLE WAS REMOVED AND AN ANGIOSEAL WAS USED TO CLOSE UP THE ACCESS SITE; THE SHEATH WAS REMOVED FROM THE PROCEDURAL FIELD AND WHEN INJECTED THROUGH IT WAS DETERMINED THAT THERE WAS A CRACK IN THE WALL OF THE SHEATH AT THE POINT IT CONNECTS TO THE HUB; THE ESTIMATED BLOOD LOSS WAS ABOUT 50ML; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND NO INTERVENTION WAS REQUIRED AND THE PATIENT'S CONDITION WASN'T AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622980 RADIFOCUS INTRODUCER II KIT INTRODUCER CATHETER DYB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TAGADERM| ANGIOSEAL