BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESHEATH

    MDR report key: 17831557 · Received September 28, 2023

    Report

    Report Number
    9681834-2023-00186
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 27, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K) NO:K062858, K082644. 1. INVESTIGATION OF THE ACTUAL SAMPLE: 1.1. ACTUAL SAMPLE UPON RECEIPT. · A PLASTIC TYPE MINI GUIDEWIRE ONLY. 1.2. VISUAL AND MAGNIFYING INSPECTIONS. · PART OF THE OUTER LAYER HAD BEEN PEELED OFF, BUT THE PEELED SECTION WAS NOT DETACHED · THE OUTER LAYER HAD BEEN PEELED OFF AT APPROXIMATELY 620MM - 650MM FROM THE DISTAL END (APPROXIMATELY 30MM). · THE FRACTURED SURFACE OF THE BODY OF MINI GUIDEWIRE WAS SMOOTH. · WHEN THE PEELED PIECE AND THE MINI GUIDEWIRE BODY WERE OVERLAPPED, THEIR SHAPES MATCHED. THEREFORE, IT WAS CONFIRMED THAT THERE WAS NO MISSING PART. 1.3. MEASUREMENT OF THE DIMENSION. · OUTER DIAMETER OF THE MINI GUIDEWIRE (NORMAL SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. 2. SIMULATION TEST: [TEST METHOD] · A FACTORY-RETAINED MINI GUIDEWIRE WAS INSERTED INTO THE METAL NEEDLE, AND REMOVAL OPERATION WAS PERFORMED. [TEST RESULT] · THE OUTER LAYER WAS PEELED OFF. · THE FRACTURED SURFACE WAS SMOOTH. 3. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER · NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD · NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. 4. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF OCCURRENCE, IT WAS INFERRED THAT SINCE THE PRODUCT WAS USED IN COMBINATION WITH A METAL NEEDLE OR METAL CANNULA, THE REMOVAL OPERATION WAS PERFORMED WITH THE OUTER LAYER OF MINI GUIDEWIRE IN CONTACT. AS A RESULT, THE URETHANE PEELED OFF. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "WARNINGS/PRECAUTIONS <WARNINGS> DO NOT USE A PLASTIC JACKETED MINI GUIDE WIRE WITH A METALLIC ENTRY NEEDLE. WITHDRAWING THE PLASTIC WIRE THROUGH THE METALLIC ENTRY NEEDLE OR ADVANCING THE ENTRY NEEDLE OVER THE PLASTIC JACKETED WIRE MAY CAUSE THE PLASTIC PART TO SHEAR, THAT MAY NECESSITATE RETRIEVAL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED PRODUCT WAS USED FOR ABLATION PROCEDURE. DURING PUNCTURE, IT WAS NOTICED THAT THE DISTAL SIDE OF MINI GUIDEWIRE WAS SPLIT. THEREFORE, IT WAS STOPPED USING. THE NEW PRODUCT WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341247 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A 230220

    Patients

    Seq Age Sex Outcome Treatment
    1 Female