BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE SHEATH

    MDR report key: 1728379 · Received June 8, 2010

    Report

    Report Number
    1118880-2010-00007
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 3, 2010
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE 2ND MARKER BAND, BUT THERE IS NO CODE AVAILABLE. RESULTS: BASED UPON EVALUATION OF USER FACILITY INFORMATION; BASED UPON TESTING OF RESERVE SAMPLES. CONCLUSIONS: THE INVOLVED SHEATH WAS NOT RETAINED BY THE USER FACILITY AND NEITHER THE PRODUCT CODE OR LOT NUMBER IS KNOWN SO NO CONCLUSION CAN BE DRAWN; BASED UPON TESTING OF RESERVE SAMPLES. AS STATED ABOVE, THE INVOLVED SHEATH WAS NOT RETAINED BY THE USER FACILITY AND NEITHER THE PRODUCT CODE OR LOT NUMBER IS KNOWN, WHICH LIMITS THE INVESTIGATION. THEREFORE, THE INVESTIGATION WAS BASED ON EVALUATION OF USER FACILITY INFORMATION AND REPRESENTATIVE RESERVE SAMPLES FROM RANDOM LOTS OF 7-FR PRODUCT. VISUAL INSPECTION OF RESERVE SAMPLES DID NOT REVEAL ANY ABNORMALITIES OR DEFECTS AND ALL SAMPLES PASSED FUNCTIONAL TESTING. ALTHOUGH THE CAUSE CANNOT BE DEFINITIVELY DETERMINED, THERE IS NO EVIDENCE THAT THE REPORTED MARKER BAND SEPARATION WAS RELATED TO DEFECT OR MALFUNCTION OF THE SHEATH. THEREFORE, THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT TO THE PHYSICIAN, BUT NO RESPONSE HAS BEEN RECEIVED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4)

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT BOTH MARKER BANDS WERE NOTED TO HAVE DISLODGED FROM A SUPERA STENT DELIVERY CATHETER FOLLOWING A STENT PLACEMENT PROCEDURE. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY REVEALED THE FOLLOWING: THERE WAS NO UNUSUAL RESISTANCE WHEN INSERTING/WITHDRAWING THE SUPERA CATHETER THROUGH THE 7-FR. PINNACLE SHEATH; AFTER THE SUCCESSFUL STENT DEPLOYMENT, THE MARKER BANDS WERE OBSERVED BY PHYSICIAN TO HAVE BECOME "DISLODGED" FROM THE SUPERA STENT DELIVERY CATHETER; ONE OF THE MARKER BANDS WAS RETRIEVED IN THE LAB USING A FILTER DEVICE; THE PATIENT WAS SENT TO SURGERY WHERE THE SECOND MARKER BAND WAS SUCCESSFULLY REMOVED; AND THE PATIENT IS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SHEATH DYB TERUMO MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SUPERA STENT DELIVERY CATHETER, FILTER DEVICE.