BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 10926557 · Received December 1, 2020

    Report

    Report Number
    9681834-2020-00239
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 1, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED FOR PRODUCT CODE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; PMA/510(K): K062858, K082644. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE REVEALED NO BLOOD CLOT IN THE APPEARANCE. MAGNIFYING INSPECTION FOUND A SCRATCH ON THE ONE-WAY VALVE. NO SCRATCH OR NO SIMILAR ANOMALY WAS OBSERVED IN THE SHEATH TUBE. X-RAY FLUOROSCOPIC INSPECTION DID NOT FIND AN ANOMALY SUCH AS A SCRATCH OR AN OBSTRUCTION INSIDE THE SHEATH TUBE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: BEFORE REMOVING OR INSERTING THE CATHETER THROUGH THE SHEATH, ASPIRATE BLOOD FROM THE 3-WAY STOPCOCK TO REMOVE ANY FIBRIN DEPOSITION WHICH MAY HAVE ACCUMULATED IN OR ON THE TIP OF THE SHEATH. INSERT THE DILATOR INTO THE VALVE CENTER OF SHEATH. FORCED DILATOR INSERTION MISSING THE VALVE CENTER MAY CAUSE VALVE DAMAGE, RESULTING IN BLOOD LEAKAGE. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ONE-WAY VALVE WAS IMPAIRED IN THE AIR-TIGHTNESS DUE TO THE SCRATCH. WHEN A SUCTION WAS DONE DURING THE PROCEDURE, AIR ENTERED THROUGH THE ONE-WAY VALVE; BLOOD IN CONTACT WITH AIR WAS EASY TO BECOME CLOTS. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RADIFOCUS INTRODUCER LL H WAS USED DURING THE PROCEDURE. DURING A CAG CASE, AN ANGIOGRAPHIC CATHETER WAS INSERTED IN THE SHEATH AND CAG WAS PERFORMED. BEFORE THE HEMOSTASIS, THEY TRIED TO MEASURE PRESSURE FROM THE SHEATH, HOWEVER, FAILED. THEY FELT STRANGE AND, WITHDREW THE CATHETER ALONG WITH THE SHEATH, AND THEN FOUND BLOOD CLOTS FROM THE SHEATH. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391482 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 200220

    Patients

    Seq Age Sex Outcome Treatment
    1