BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH SLENDER

    MDR report key: 8944065 · Received August 29, 2019

    Report

    Report Number
    1118880-2019-00232
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 29, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    UDI-DI
    00389701012049
    PMA / PMN Number
    K173831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE GUIDEWIRE FROM THE GLIDESHEATH SLENDER KIT WAS RETURNED FOR EVALUATION. NO OTHER COMPONENTS WERE RETURNED. VISUAL INSPECTION REVEALED THAT THERE WERE NO OUTWARD ANOMALIES NOTED ON THE WIRE TURNS. THE WIRE WAS EXAMINED FOR SWELLS AND GAPS IN THE SURFACE AND NONE WERE FOUND. THERE WERE NO BREAKS IN THE COIL. THE END WELD WAS EXAMINED, AND NO ANOMALIES WERE NOTED. THE ALLEGED "BUBBLE" AT THE END OF THE WIRE IS A MANUFACTURING FEATURE AND NOT AN ANOMALY. FUNCTIONAL TESTING WAS PERFORMED ON A 21G METALLIC NEEDLE FROM A MANUFACTURER RETAINED GLIDESHEATH SLENDER KIT (LOT 170221); THE WIRE WAS ATTEMPTED TO BE INSERTED IN THE NEEDLE BUT WAS UNABLE TO GO THROUGH. THE OUTER DIAMETER OF THE WIRE WAS MEASURED AND FOUND TO BE 0.061MM WHICH CORRESPONDS TO THE 0.025" GUIDEWIRE AND NOT THE 0.021 WIRE WHICH COMES WITH THE 80-1050 KIT. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE CAUSE OF THE ISSUE IS DUE TO THE ATTEMPT AT INSERTION OF A LARGER GAGE GUIDEWIRE INTO A SMALLER BORE NEEDLE. SINCE NO OTHER ACCESSORY COMPONENTS WERE RETURNED BY THE CUSTOMER, THE CAUSE OF THIS MISMATCH CANNOT BE FOUND WITH THE AVAILABLE INFORMATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN ISSUE WITH THE GLIDESHEATH KIT WIRE, THERE'S A BUBBLE AT THE TIP OF THE WIRE PREVENTING IT FROM BEING INSERTED INTO THE SHEATH. THE EVENT OCCURRED PRE-TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 14AUG2019. THE PROCEDURE BEING PERFORMED WAS A RADIAL ACCESS FOR PERCUTANEOUS CORONARY INTERVENTION. THE OUTCOME WAS A SUCCESS AFTER THEY OPENED A NEW SHEATH. THE PATIENT WAS REPORTED TO BE COMPLETELY FINE; THEY NOTICED THE ISSUE BEFORE THE SHEATH WENT INTO THE BODY. THE PATIENT WAS NOT AFFECTED IN ANY WAY BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737548 GLIDESHEATH SLENDER INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A XG05 00389701012049

    Patients

    Seq Age Sex Outcome Treatment
    1