BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE DESTINATION RENAL GUIDING SHEATH

    MDR report key: 1355105 · Received January 9, 2009

    Report

    Report Number
    1118880-2009-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 11, 2008
    Report Date
    December 11, 2008
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    PMA / PMN Number
    K012854
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER STATED THAT HE MAY HAVE KINKED THE SHEATH DURING USE, BUT THIS CANNOT BE CONFIRMED WITHOUT EVALUATION OF THE INVOLVED GUIDING SHEATH - THE INVOLVED GUIDING SHEATH WAS NOT RETAINED BY THE USER FACILITY AND NEITHER THE PRODUCT CODE OR LOT NUMBER IS KNOWN. THEREFORE, THE INVESTIGATION WAS LIMITED TO AN ASSESSMENT OF INFORMATION PROVIDED BY THE USER FACILITY. AS STATED ABOVE, THE INVOLVED GUIDING SHEATH WAS NOT RETURNED FOR EVALUATION AND NEITHER THE LOT NUMBER NOR PRODUCT CODE IS KNOWN, WHICH LIMITS THE INVESTIGATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION. HOWEVER, THE DEVICE WAS IN USE DURING THE REPORTED EVENT WHICH REQUIRED INTERVENTION. THEREFORE, THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER REMOVAL OF A SUPERA STENT DELIVERY CATHETER THROUGH A PINNACLE SHEATH THE PHYSICIAN OBSERVED THAT THE MARKER BANDS HAD DISLODGED FROM THE STENT DELIVERY CATHETER. FOLLOW-UP COMMUNICATION WITH THE PHYSICIAN REVEALED THE FOLLOWING: HE "NOTICED TROUBLE" REMOVING THE SHEATH AND STATED THAT HE MAY HAVE "KINKED THE SHEATH AT THE COMMON FEMORAL PUNCTURE SITE WHICH MADE IT DIFFICULT TO REMOVE"; THE DISLODGED MARKERS WERE FIRST NOTED WHILE INSERTING THE STENT DILATION BALLOON; HE WAS ABLE TO SUCCESSFULLY RETRIEVE THE MARKER BANDS USING THE STENT DILATION BALLOON; AND THE STENT PLACEMENT PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 018 STEELCORE WIRE| BALLOON CATHETER| SUPERA STEN & DELIVERY CATHETER