BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14 SHIDEN HP

    MDR report key: 20307341 · Received September 26, 2024

    Report

    Report Number
    3002808904-2024-00007
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 30, 2024
    Report Date
    August 30, 2024
    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 THE PUNCTURE HOLE AT THE TIME OF REMOVAL OF THE DEVICE WAS LOCATED IN THE BALLOON ABOUT 203 MM FROM 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: DUE TO THE DEFECTIVE DEFLATION OF THE BALLOON, IT WAS DETERMINED THAT THE PRODUCT CONSTITUTED A SERIOUS HEALTH HAZARD BECAUSE THE BALLOON WAS REMOVED FROM THE BODY AFTER BEING RUPTURED BY PUNCTURING THE BALLOON 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

    THE LESION WAS DILATED WITH "14 SHIDEN HP 3.5-200MM" DURING TREATMENT OF A BELOW-KNEE ARTERY, BUT THE BALLOON FAILED TO DEFLATE AND COULD NOT BE REMOVED. THE BALLOON WAS RUPTURED IN THE VESSEL WITH A PUNCTURE NEEDLE FROM OUTSIDE THE BODY, AND THE DEVICE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304142 14 SHIDEN HP PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR123563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other