BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHICHO NEO

    MDR report key: 18665082 · Received February 7, 2024

    Report

    Report Number
    3002808904-2024-00001
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 19, 2024
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED. THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE SHAFT-PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. THE ACTUAL DEVICE WAS RETURNED. IT WAS CONFIRMED THAT THE BALLOON WAS RUPTURED AT APPROXIMATELY 11 MM TO 46 MM FROM THE BALLOON TIP. THIS PRODUCT WAS CONFIRMED TO PASS A GUIDE WIRE (0.035INCH) WITHOUT RESISTANCE. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS ASSUMED THAT LESIONS OR OTHER FACTORS TEMPORARILY PREVENTED CONTRACTION AND MADE EXTRACTION DIFFICULT.

    Description of Event or Problem · 0

    OHICHO NEO IS AN OTW-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.035 INCH GUIDEWIRE. OHICHO NEO HAS NO APPROVAL IN USA. HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON THE SIMILAR DEVICE FOR "METACROSS OTW" (OTW TYPE PTA BALLOON DILATATION CATHETER, 0.035" GUIDEWIRE COMPATIBLE) IN US UNDER 510(K)#: K152080". THE PRODUCT IN QUESTION WAS INFLATED AT THE LESION SITE. AFTER INFLATION, ATTEMPTS WERE MADE TO DEFLATE THE PRODUCT, BUT THIS WAS NOT POSSIBLE. THE PRODUCT COULD NOT BE REMOVED FROM THE PATIENT. THE PRODUCT WAS PUNCTURED THROUGH THE SKIN AND REMOVED BY POPPING A BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765343 OHICHO NEO OHICHO NEO LIT KANEKA CORPORATION SR083588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other