BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 SHIDEN HP

    MDR report key: 21837275 · Received April 14, 2025

    Report

    Report Number
    3002808904-2025-00014
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 19, 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) THE DEVICE WAS NOT RETURNED. 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: THE RUPTURED FRAGMENTS RETAINED IN THE BODY WERE SURGICALLY RETRIEVED; THEREFORE, THE EVENT WAS ASSESSED AS A SERIOUS INJURY. BASED ON THE INVESTIGATION, THE EVENT IS CONSIDERED TO BE PROCEDURE-RELATED, LIKELY CAUSED BY EXCESSIVE TRACTION APPLIED AFTER THE BALLOON RUPTURED AND WAS PULLED INTO THE SHEATH WITHOUT COMPLETE DEFLATION, RESULTING IN THE RUPTURED PORTION GETTING CAUGHT AT THE SHEATH TIP. NO ISSUES WERE IDENTIFIED WITH THE PRODUCT'S DESIGN OR MANUFACTURING.

    Description of Event or Problem · 0

    A GUIDING SHEATH WAS INSERTED VIA THE RIGHT RADIAL ARTERY, AND TREATMENT WAS PERFORMED FOR THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY (CIA-EIA). AFTER PLACEMENT OF AN ILIAC STENT, POST-DILATATION WAS PERFORMED USING THE SUBJECT DEVICE. FOLLOWING EXPANSION OF THE EIA, THE CIA WAS ALSO DILATED, WHICH IMMEDIATELY RESULTED IN A RUPTURE. THE DEVICE WAS THEN ATTEMPTED TO BE WITHDRAWN INTO THE SHEATH, DESPITE INCOMPLETE DEFLATION, BUT COULD NOT BE FULLY RETRACTED. WHEN TRACTION WAS APPLIED TO WITHDRAW THE DEVICE PROXIMALLY UP TO THE UPPER ARM, ONLY THE SHEATH WAS REMOVED, LEAVING THE GUIDEWIRE AND BALLOON RETAINED INSIDE THE BODY. SURGICAL INTERVENTION WAS CONDUCTED TO RETRIEVE THE RETAINED COMPONENTS. AFTERWARD, THROMBUS REMOVAL WAS COMPLETED USING A THROMBECTOMY CATHETER, AND THE PROCEDURE WAS CONCLUDED. THE PATIENT'S PROGNOSIS WAS GOOD AND HE WAS DISCHARGED WITHOUT ISSUE. IT SHOULD BE NOTED THAT THE BALLOON, SHEATH, AND OTHER COMPONENTS WERE FOUND TO HAVE BEEN SEVERED DURING RETRIEVAL AND WERE SUBSEQUENTLY DISCARDED, RENDERING THEM UNRECOVERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111842 18 SHIDEN HP PTA BALLOON DILATATION CATHERTER LIT KANEKA CORPORATION SR103342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other