BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDESHEATH

    MDR report key: 17693414 · Received September 6, 2023

    Report

    Report Number
    9681834-2023-00174
    Event Type
    Death
    Date Received
    September 6, 2023
    Date of Event
    August 7, 2023
    Report Date
    September 6, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INSPECTION OF THE ACTUAL SAMPLE: SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, DETAILED INVESTIGATION COULD NOT BE PERFORMED. 2. HISTORY INVESTIGATION: REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# FOUND NO ANOMALY. A SEARCH OF THE PAST COMPLAINT FILE OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER FOUND NO OTHER SIMILAR REPORT. 3. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORDS. SINCE THE CONDITION OF ACTUAL SAMPLE COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: VASOSPASM, BLEEDING, INFECTION, TISSUE TRAUMA, PERFORATION OF VESSEL WALL, AIR EMBOLISM, PSEUDO ANEURYSM FORMATION, HEMATOMA, THROMBUS FORMATION." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A 9F 25CM SHEATH WAS USED URGENTLY IN NEUROSURGERY. DURING PUNCTURING THE FEMORAL ARTERY, THE EXTERNAL ILIAC ARTERY WAS PERFORATED WITH THE DILATOR. VASCULAR PERFORATION WAS CAUSED BY USE OF SHEATH, WHICH RESULTED IN PATIENT'S DEATH. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986990 GLIDESHEATH INTRODUCER, CATHETER DYB TERUMO MEDICAL CORPORATION N/A 230427

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death