BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14 SHIDEN HP

    MDR report key: 21371230 · Received February 13, 2025

    Report

    Report Number
    3002808904-2025-00004
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 22, 2025
    Report Date
    January 22, 2025
    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 "14 SHIDEN HP" IS A RAPID-EXCHANGE (RX) TYPE PTA BALLOON DILATATION CATHETER COMPATIBLE WITH 0.014"GUIDEWIRE (GW). "14 SHIDEN HP" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSPERIO RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE WITH 0.014" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152877. 1. RESULTS OF INVESTIGATION 1) THE REMNANT FRAGMENTS OF THE CONCERNED DEVICE WERE CONFIRMED TO BE ABOUT 45MM FOR THE BALLOON AND 46.5MM FOR THE INNER TUBE, INCLUDING 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: WE HAVE DETERMINED THIS TO BE A SERIOUS ADVERSE HEALTH EFFECT, AS THE UNRECOVERED FRAGMENTS OF THE CONCERNED DEVICE RESULTED IN FOREIGN BODY RETENTION FOLLOWING STENT CRIMPING. WE CONCLUDE THAT THIS INCIDENT WAS ATTRIBUTED TO LESION-RELATED AND PROCEDURE-RELATED FACTORS, SPECIFICALLY WHEN EXCESSIVE FORCE WAS APPLIED AFTER RUPTURE WHEN THE DEVICE BECAME STUCK AT THE LESION SITE. WE HAVE DETERMINED THERE ARE NO ISSUES WITH THE PRODUCT'S MANUFACTURING OR DESIGN.

    Description of Event or Problem · 0

    WHILE DILATING A HEAVILY CALCIFIED LESION IN THE SFA (SUPERFICIAL FEMORAL ARTERY, IPSILATERAL APPROACH) WITH "14 SHIDEN HP", A RUPTURE OCCURRED AT 20 ATM (RECOMMENDED INFLATION PRESSURE), AND "14 SHIDEN HP" BECAME TRAPPED IN THE LESION. ATTEMPTS TO REMOVE THE SYSTEM WERE UNSUCCESSFUL, RESULTING IN BALLOON RUPTURE STARTING AT THE POINT WHERE IT WAS STUCK. THE BALLOON FRAGMENT REMAINED WITHIN THE LESION FROM ITS MIDDLE PORTION TO THE TIP, MAKING RETRIEVAL IMPOSSIBLE. SUBSEQUENTLY, "VIABAHN" WAS USED TO COMPRESS THE REMAINING FRAGMENTS AGAINST THE VESSEL WALL, AFTER WHICH THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867512 14 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR114726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other