BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 SHIDEN HP

    MDR report key: 22846520 · Received August 19, 2025

    Report

    Report Number
    3002808904-2025-00031
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 24, 2025
    Report Date
    July 25, 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 SUBJECT TO THIS REPORTED EVENT, "18 SHIDEN HP", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.018" GUIDEWIRE(GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILARDEVICES FOR"CROSSTELLA RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1. RESULTS OF INVESTIGATION 1) IT WAS CONFIRMED THAT THE BALLOON HAD A LONGITUDINAL RUPTURE RANGING FROM ABOUT 13 MM TO 37 MM FROM THE TIP, AND NO OTHER ABNORMALITIES WERE OBSERVED. 2) THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WERE REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. 2. PROBABLE CAUSE AND COMMENTS: ALTHOUGH THE BALLOON RUPTURED AT A PRESSURE BELOW THE NOMINAL INFLATION PRESSURE, NO ISSUES WERE FOUND IN THE MANUFACTURING RECORDS. THEREFORE, IT IS PRESUMED THAT THE RUPTURE AND PARTIAL VASCULAR INJURY WERE CAUSED BY THE PATIENT'S VASCULAR CONDITION (SUCH AS CALCIFICATION OR FRAGILITY) AND THE INFLUENCE OF CONCOMITANT DEVICES. ACCORDINGLY, IT WAS DETERMINED THAT THERE WERE NO PROBLEMS WITH THE PRODUCT'S MANUFACTURING OR DESIGN. IN ADDITION, AS THE FOLLOWING STATEMENT IS INCLUDED IN THE IFU, THIS EVENT WAS DETERMINED TO BE A KNOWN ISSUE. [COMPLICATIONS]. DEVICE FAILURES:BALLOON RUPTURE. ADVERSE EVENTS:VASCULAR DISSECTION, VASCULAR PERFORATION, VASCULAR RUPTURE.

    Description of Event or Problem · 0

    IN A CASE OF RESTENOSIS OF THE LEFT COMMON ILIAC ARTERY, AN APPROACH WAS MADE VIA THE RIGHT FEMORAL ARTERY USING A DESTINATION 6FR SHEATH AND A JUPITER FC GUIDEWIRE. DURING BALLOON DILATION WITH THE DEVICE, THE BALLOON RUPTURED AT A PRESSURE BELOW THE NOMINAL INFLATION PRESSURE, RESULTING IN PARTIAL VASCULAR INJURY. HEMOSTASIS WAS ACHIEVED BY BALLOON DILATION USING A SENRI BALLOON, AND SUBSEQUENTLY, A VIABAHN VBX (BALLOON-EXPANDABLE STENT GRAFT) WAS DEPLOYED TO COMPLETE THE TREATMENT. THE PATIENT SHOWED NO POST-PROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315336 18 SHIDEN HP PTA BALLOON DILATATION CATHERTER LIT KANEKA CORPORATION SR014296

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other