BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 9171287 · Received October 9, 2019

    Report

    Report Number
    9681834-2019-00171
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 9, 2019
    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

    NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. ADDRESS: (B)(6); 510(K): K062858, K082644. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SHEATH REVEALED A TEAR HAD BEEN GENERATED ON APPROXIMATELY 100MM FROM THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF THE TORN SEGMENT FOUND ABRASIONS HAD BEEN GENERATED ON THE SEGMENT ADJACENT TO THE TEAR. THE TORN SURFACE WAS FOUND SMOOTH. BASED ON THIS, IT IS PRESUMED THAT THE TEAR WAS CAUSED BY A SHARP OBJECT. THE SHEATH TUBE WAS CUT CROSSWISE NEAR THE TEAR AND THE CUT CROSS SECTION WAS INSPECTED UNDER A MAGNIFIER. THE WALL THICKNESS WAS CONFIRMED TO MEET THE SPECIFICATION. NO UNEVENNESS IN THE WALL THICKNESS WAS OBSERVED. REPRODUCTIVE TESTING WAS PERFORMED; A FACTORY-RETAINED SHEATH SAMPLE WAS TORN WITH A SCALPEL ON THE TUBE. THE TORN SURFACE WAS FOUND SMOOTH, AND THE STATE OF THE DAMAGE WAS CONFIRMED TO BE SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: WARNING/PRECAUTIONS] PRECAUTIONS.DO NOT SCRATCH THE SHEATH WITH NEEDLE POINT, CUTTING TOOL, OR OTHER EDGED TOOLS. 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 A SHARP OBJECT (E.G. A SCALPEL) CAME INTO CONTACT WITH THE ACTUAL SAMPLE FROM THE OUTSIDE OF THE SHEATH TUBE, RESULTING THE GENERATION OF THE TEAR AND ABRASION. 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 AFTER INSERTING THE GLIDE SHEATH, THEY FOUND A BLOOD LEAK FROM THE SHEATH TUBE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 10ML. THEY EXCHANGED TO A NEW SHEATH, AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965374 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA NA 190424

    Patients

    Seq Age Sex Outcome Treatment
    1