BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO GLIDESHEATH

    MDR report key: 3812178 · Received May 15, 2014

    Report

    Report Number
    9681834-2014-00118
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K122980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD LOSS - ALTHOUGH THERE WAS NO REPORTED IMPACT TO THE PATIENT, THE EVENT DESCRIPTION INDICATES THAT SOME MINOR BLOOD LOSS DID OCCUR. THE ESTIMATED AMOUNT OF BLOOD LOSS WAS UNABLE TO BE DETERMINED THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN JAPAN. VISUAL INSPECTION OF THE RETURNED DEVICE DID FIND THAT THE SHEATH TUBE HAD BEEN KINKED AT 56MM, 71MM, 82MM, AND 98MM FROM THE DISTAL END OF THE SHEATH. IT IS LIKELY, HOWEVER THESE KINKS WOULD NOT BE CORRELATED WITH THE REPORTED EVENT. OTHER VISIBLE ANOMALIES WERE NOT FOUND. LEAK TESTING WAS PERFORMED ON THE ACTUAL SAMPLE, NO LEAK WAS NOTED. THE SHEATH WAS INSERTED OVER THE INVOLVED CATHETER AND THEN LEAKED TESTED, A LEAK WAS OBSERVED. A LEAK WAS ALSO OBSERVED WHEN THE SHEATH WAS INSERTED OVER A FACTORY RETAINED GUIDEWIRE AND LEAK TESTED. THE CROSS-CUT VALVE WAS INSPECTED UNDER MAGNIFICATION IN BOTH CASES. A GAP WAS FOUND TO HAVE GENERATED BETWEEN THE CROSS-CUT VALVE AND THE DEVICE INSERTED IN IT. THE CROSS-CUT VALVE ITSELF WAS CLOSELY INSPECTED UNDER MAGNIFICATION. IT WAS NOTED TO HAVE A FLAW OFF CENTER OF THE SLIT, PENETRATING THROUGH THE BACK SIDE. THIS FLAW APPEARS TO BE THE CAUSE OF THE GENERATION OF THE GAP BETWEEN THE CROSS-CUT VALVE AND THE INVOLVED CATHETER AND BETWEEN THE CROSS-CUT VALVE AND THE GUIDEWIRE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FROM THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION IS CONSISTENT WITH THE DILATOR BEING INSERTED OFF-CENTER OF THE CROSSCUT VALVE, DAMAGING THE VALVE AND RESULTING IN THE LEAKAGE NOTED. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE PRODUCT LABELING WITH STATEMENTS SUCH AS THE FOLLOWING: "INSERT THE DILATOR INTO THE CENTER OF THE SHEATH VALVE. FORCED INSERTION OF THE DILATOR WHICH MISSES THE CENTER OF THE SHEATH VALVE MAY CAUSE DAMAGE, AND RESULT IN BLOOD LEAKAGE." 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 EXCESSIVE BLEEDING THROUGH THE VALVE OF THE SHEATH. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED: THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT'S CONDITION IS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291714 TERUMO GLIDESHEATH CATHETER INTRODUCER DYB TERUMO CORPORATION, ASHITAKA NA 140114

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETERS| WIRES