BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14 SHIDEN HP

    MDR report key: 22296049 · Received June 20, 2025

    Report

    Report Number
    3002808904-2025-00023
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 27, 2025
    Report Date
    May 27, 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)IT WAS CONFIRMED THAT, DURING RETRIEVAL OF THE DEVICE, THE OPERATOR INTENTIONALLY CREATED TWO PUNCTURE HOLES IN THE BALLOON SECTION ABOUT 46 MM FROM THE DISTAL TIP AND ONE PUNCTURE HOLE IN THE BALLOON SECTION ABOUT 185 MM FROM THE DISTAL TIP, FOR DECOMPRESSION PURPOSES. 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: DUE TO THE DEFECTIVE DEFLATION OF THE BALLOON, IT WAS DETERMINED THAT THE EVENT CONSTITUTED A HEALTH HAZARD BECAUSE THE BALLOON WAS REMOVED FROM THE BODY AFTER BEING RUPTURED BY PUNCTURING IT IN THE BLOOD VESSEL FROM OUTSIDE THE BODY WITH A PUNCTURE NEEDLE. SINCE NO ABNORMALITY WAS FOUND IN THE MANUFACTURING RECORDS, IT WAS INFERRED THAT THE TECHNIQUE CAUSED THE EVENT DUE TO INSUFFICIENT DEFLATION OF THE BALLOON, AND IT WAS DETERMINED THAT THERE WERE NO PROBLEMS IN MANUFACTURING OR DESIGN.

    Description of Event or Problem · 0

    A "14 SHIDEN HP 2.5-200MM" BALLOON CATHETER WAS USED FOLLOWING THE USE OF A VIBRATION-TYPE PERIPHERAL CROSSING CATHETER TO TREAT AN ATA OCCLUSIVE LESION. THE DEVICE WAS SUCCESSFULLY DELIVERED TO THE LESION SITE WITHOUT SIGNIFICANT RESISTANCE. THE BALLOON WAS INFLATED TO 24 ATM, WHICH WAS BELOW THE RATED BURST PRESSURE (RBP) OF 30 ATM. HOWEVER, DURING DEFLATION, PRESSURE COULD NOT BE SUFFICIENTLY WITHDRAWN, AND THE BALLOON FAILED TO DEFLATE. MULTIPLE DEFLATION ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL. ULTIMATELY, TWO PUNCTURES WERE MADE EXTERNALLY TO THE BODY TO RELEASE THE PRESSURE, WHICH ALLOWED FOR SUCCESSFUL RETRIEVAL OF THE DEVICE. A NEW DEVICE OF THE SAME MODEL AND SIZE WAS SUBSEQUENTLY USED AND FUNCTIONED WITHOUT ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685454 14 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR103354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other