BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHICHO NEO

    MDR report key: 22683386 · Received July 31, 2025

    Report

    Report Number
    3002808904-2025-00028
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    June 27, 2025
    Report Date
    June 27, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    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 TIP WAS BROKEN AT APPROXIMATELY 25 MM FROM THE DISTAL TIP OF THE PRODUCT IN QUESTION, AND IT WAS CONFIRMED THAT THERE WAS A SCRATCH AT THE TIP. THE TIP AND PROXIMAL SIDE FRACTURE FRAGMENTS WERE RECOMBINED AND THE BALLOON LENGTH WAS CONFIRMED TO BE APPROXIMATELY 40 MM. THE DISTAL RING MARKER WAS NOT RETURNED. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS ASSUMED THAT THE BALLOON RUPTURED DUE TO CONTACT WITH A HARD LESION, SUCH AS CALCIFICATION, AND THAT THE RUPTURED PART OF THE BALLOON CAUGHT ON THE SHEATH OR OTHER DEVICE WHEN IT WAS REMOVED, CAUSING THE BALLOON AND CATHETER TO RUPTURE BECAUSE IT WAS PULLED IN THAT STATE.

    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". A BALLOON(5.0?~40MM) RUPTURE OCCURRED WHEN THE PRODUCT IN QUESTION WAS DILATED AT APPROXIMATELY 20 ATM IN A STRONGLY CALCIFIED LESION. DURING REMOVAL, THE RUPTURED PART WAS CAUGHT IN THE SHEATH AND COULD NOT BE REMOVED, SO THE SHEATH WAS REMOVED TOGETHER WITH THE RUPTURE. AFTER REMOVAL, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE DISTAL RING MARKER WAS PRESENT IN THE SHEATH. SUBSEQUENTLY, THE SAME PATIENT WAS REFERRED TO ANOTHER CENTER FOR TREATING INCREASED PRESSURE IN THE SHUNT BY SURGERY, AND A THROMBUS CONTAINING PART OR RUPTURED BALLOON WAS FOUND IN THE SUBCLAVIAN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220954 OHICHO NEO OHICHO NEO LIT KANEKA CORPORATION SR035614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other