BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 SHIDEN HP

    MDR report key: 19507888 · Received June 11, 2024

    Report

    Report Number
    3002808904-2024-00004
    Event Type
    Injury
    Date Received
    June 11, 2024
    Report Date
    June 3, 2024
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE "18 SHIDEN HP" IS A RAPID-EXCHANGE (RX) TYPE PTA BALLOON DILATATION CATHETER COMPATIBLE WITH 0.018" GUIDEWIRE (GW). "18 SHIDEN HP" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE WITH 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1. RESULTS OF INVESTIGATION 1) THE DEVICE WAS FOUND TO BE RUPTURED (LONGITUDINALLY CRACKED) AT THE BALLOON BETWEEN ABOUT 8MM AND 25MM FROM THE TIP. 2)THE DEVICE HISTORY RECORDS (DHR-BATCH RECORD) OF THE CONCERNED DEVICE WERE REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. 2. PROBABLE CAUSE AND COMMENTS: THE HEMATOMA FORMED WHEN THE ENTIRE SHEATH WAS REMOVED FROM THE DEVICE AND CAUSED BLEEDING THAT DID NOT STOP EVEN AFTER THE PROCEDURE WAS COMPLETED, RESULTING IN A TEMPORARY SHOCK SYMPTOMS, AND BLOOD TRANSFUSION PROCEDURES WERE PERFORMED. THE INCIDENT WAS PRESUMED TO BE CAUSED BY THE LESION AND THE PROCEDURE DUE TO EXCESSIVE PULLING WHEN THE SHEATH WAS REMOVED AFTER RUPTURE, AND IT WAS DETERMINED THAT THERE WERE NO PROBLEMS IN MANUFACTURING OR DESIGN.

    Description of Event or Problem · 0

    "18 SHIDEN HP 6.0-40 MM" WAS USED FOR AN ILIAC, HIGHLY CALCIFIED LESION. WHEN THE SHEATH WAS EXTENDED, IT COULD NOT BE RETRACTED INTO THE SHEATH DUE TO RUPTURE UNDER NOMINAL PRESSURE, AND THE ENTIRE SHEATH WAS REMOVED. THIS RESULTED IN A HEMATOMA AT THE SHEATH INSERTION SITE. THE SHAFT OF THIS SHIDEN WAS CUT AND REMOVED, AND THE SHEATH WAS REINSERTED TO RESUME TREATMENT. THE BLEEDING DID NOT STOP EVEN AFTER THE PROCEDURE WAS COMPLETED, AND THE PATIENT TEMPORARILY WENT INTO SHOCK, AND 6 UNITS OF BLOOD TRANSFUSION WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824085 18 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR113089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other