BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14 SHIDEN HP

    MDR report key: 21301564 · Received February 4, 2025

    Report

    Report Number
    3002808904-2025-00003
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 20, 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 CONCERNED DEVICE WAS NOT RETURNED. 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: SINCE THE FOREIGN OBJECT REMAINING IN THE BODY HAS NOT BEEN RETRIEVED FOR EXAMINATION, WE CANNOT DEFINITIVELY CONFIRM THAT IT IS THE PROTECTION PARTS OF THE CONCERNED DEVICE. HOWEVER, BASED ON CIRCUMSTANTIAL EVIDENCE, IT HAS BEEN DETERMINED THAT WHILE THE PHYSICIAN PERFORMED THE PROCEDURE WITH THE PROTECTION PARTS INSERTED IN THE BODY WITHOUT REMOVING IT, SUFFICIENT DILATION WAS NOT ACHIEVED, AND THERE IS AN EXTREMELY HIGH PROBABILITY THAT THE PROTECTION PARTS WAS RETAINED IN THE BODY DUE TO FACTORS DURING THIS PROCESS. ALTHOUGH THIS INCIDENT HAS BEEN DETERMINED TO BE CAUSED BY THE METHOD OF USE, MDR WILL BE SUBMITTED DUE TO THE RETENTION OF A FOREIGN OBJECT IN THE BODY.

    Description of Event or Problem · 0

    "14 SHIDEN HP" WAS USED FOR ADDITIONAL DILATATION OF THE POSTERIOR TIBIAL ARTERY (CHRONIC TOTAL OCCLUSION LESION) FOLLOWING INITIAL DILATATION WITH ANOTHER MANUFACTURER'S BALLOON. DURING THE PROCEDURE, "14 SHIDEN HP" WAS INSERTED INTO THE LESION WITHOUT REMOVING THE PROTECTION PARTS BUT FAILED TO DILATE AND HAD TO BE WITHDRAWN. SUBSEQUENTLY, ATTEMPTS TO REINSERT USING ANOTHER MANUFACTURER'S BALLOON WERE UNSUCCESSFUL, LEADING TO TERMINATION OF THE PROCEDURE. AFTER THE PROCEDURE, FAINT BLOOD FLOW WAS OBSERVED IN THE POSTERIOR TIBIAL ARTERY, SO THE PATIENT WAS MONITORED AND DISCHARGED THREE DAYS POST-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64908 14 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR034737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other