BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH A KIT

    MDR report key: 3832869 · Received May 27, 2014

    Report

    Report Number
    9681834-2014-00157
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 27, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K122980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS/CONCLUSIONS - BASED ON EVALUATION OF USER FACILITY INFORMATION AND THE RETURNED SAMPLE; BASED UPON EVALUATION OF THE UNDAMAGED PORTION OF THE RETURNED SAMPLE. THE INVOLVED DEVICE WAS RETURNED AND EVALUATED BY QA AT THE MANUFACTURING FACILITY. EXAMINATION CONFIRMED THAT THERE WAS A DAMAGED SEGMENT AT APPROXIMATELY 101MM FROM THE DISTAL END. MAGNIFYING INSPECTION OF THE DAMAGED SEGMENT FOUND THAT THE URETHANE COAT HAD COME OFF PARTIALLY IN THE DISTAL DIRECTION AND THE SURFACE OF THE COATING HAD BECOME BUMPY, WITH THE GENERATION OF A DIAGONAL ABRASION IN THE DISTAL DIRECTION STARTING FROM THE BUMP. THE ACTUAL SAMPLE WAS INSERTED INTO A CURRENT GLIDESHEATH SLENDER DILATOR OF THE TYPE APPLICABLE TO 0.02IN GUIDE WIRE FROM THE DISTAL END OF THE DILATOR. THIS ATTEMPT RESULTED IN STICKING OF THE DAMAGED SEGMENT OF THE ACTUAL SAMPLE AT THE DISTAL END OF THE DILATOR. NO FARTHER INSERTION WAS FOUND TO BE POSSIBLE. THERE WAS NO OTHER ANOMALY OR DAMAGE ON THE ACTUAL SAMPLE. INSPECTION AND TESTING WAS COMPLETED ON UNDAMAGED PORTIONS OF THE WIRE AND IT WAS CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION AND THE INVESTIGATION FINDINGS, IT IS LIKELY THAT THE URETHANE COATING ON THE ACTUAL SAMPLE GOT DAMAGED WHEN THE ACTUAL SAMPLE WAS INSERTED INTO THE INVOLVED DILATOR, THE DAMAGE SEGMENT WAS CAUGHT IN THE DISTAL END OF THE DILATOR. AS A CAUSE THE GENERATION OF THE DAMAGE ON THE ACTUAL SAMPLE, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS PULLED BACK FROM A METALLIC ENTRY NEEDLE IN A CURVED SHAPE, WHEN THE URETHANE COATING GOT DAMAGED BY THE DISTAL TIP OF THE NEEDLE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE BY STATEMENTS INCLUDING, "DO NOT USE A METAL CANNULA AS AN ENTRY NEEDLE. WITHDRAWING THE MINI GUIDE WIRE THROUGH A METAL CANNULA OR ADVANCING A METAL CANNULA OVER THE MINI GUIDE WIRE MAY RESULT IN SHEARING OF THE MINI GUIDE WIRE OR SCRAPING OF THE PLASTIC COATING." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN 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 AN ISSUE WITH FOUR OF THE WIRES ON THE GLIDESHEATH SLENDER A-KIT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED: WHILE ADVANCING THE WIRE THROUGH THE SLENDER IT APPEARED TO HAVE A BUMP IN THE PLASTIC JACKET THAT PROHIBITED IT FROM ADVANCING; AND A COOK SINGLE WALL NEEDLE WAS USED INSTEAD OF THE STANDARD IV CATH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311093 GLIDESHEATH A KIT GLIDESHEATH SLENDER DYB TERUMO CORPORATION, ASHITAKA NA 131125

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK SINGLE WALL NEEDLE