BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 23886707 · Received December 24, 2025

    Report

    Report Number
    3002808904-2025-00039
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 16, 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 DEVICE SUBJECT TO THIS REPORTED EVENT, "SENRI", 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 SIMILAR DEVICES FOR"CROSSTELLA RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1. RESULTS OF INVESTIGATION: 1) IT WAS CONFIRMED THAT THE SHAFT HAD FRACTURED APPROXIMATELY 530 MM FROM THE DISTAL END. IN ADDITION, THE SECTION FROM THE GUIDEWIRE PORT TOWARD THE PROXIMAL SIDE WAS FOUND TO BE SIGNIFICANTLY ELONGATED, WITH THE EFFECTIVE LENGTH OF THE CATHETER EXTENDED BY ABOUT 420 MM. FURTHERMORE, IT WAS CONFIRMED THAT THERE WERE NO LEAKS OR RUPTURES IN THE BALLOON SECTION. 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: ALL FRACTURED FRAGMENTS WERE SUCCESSFULLY RETRIEVED; HOWEVER, THE RETRIEVAL REQUIRED AN ADDITIONAL PUNCTURE AT A SITE DIFFERENT FROM THE INITIAL ACCESS POINT (THE LEFT FEMORAL ARTERY INSTEAD OF THE RIGHT DISTAL RADIAL ARTERY), NECESSITATING AN INVASIVE PROCEDURE. THEREFORE, THIS EVENT WAS ASSESSED AS A SERIOUS HEALTH HAZARD. IT IS PRESUMED THAT MULTIPLE FACTORS CONTRIBUTED TO THIS PROCEDURE-RELATED EVENT, SUCH AS THE POSSIBILITY THAT THE BALLOON REMAINED CAUGHT AT THE SHEATH TIP AND BECAME DIFFICULT TO WITHDRAW (INCLUDING TEMPORARY BALLOON DEFLATION FAILURE), AND THE STRONG TENSILE FORCE APPLIED WHILE CONTINUING THE WITHDRAWAL MANEUVER UNDER THESE CONDITIONS. BASED ON THIS ASSESSMENT, IT WAS DETERMINED THAT THERE WERE NO ISSUES WITH MANUFACTURING OR DESIGN.

    Description of Event or Problem · 0

    SUMMARY: DURING TREATMENT OF BOTH ILIAC ARTERIES, THE PRODUCT WAS USED FOR POST-DILATATION AFTER STENT PLACEMENT. SUBSEQUENTLY, DURING REMOVAL, THE DEVICE COULD NOT BE RETRACTED INTO THE SHEATH, AND THE SHAFT FRACTURED. DETAILS: ACCESS WAS OBTAINED VIA THE RIGHT DISTAL RADIAL ARTERY USING AN R2P DESTINATION SLENDER GUIDING SHEATH (6 FR, TERUMO). TWO R2P MISAGO SELF-EXPANDING PERIPHERAL STENTS (TERUMO) WERE DEPLOYED IN THE RIGHT ILIAC ARTERY, FOLLOWED BY POST-DILATATION WITH THE PRODUCT. POST-DILATATION WAS ALSO PERFORMED IN THE LEFT ILIAC ARTERY IN THE SAME MANNER. DURING REMOVAL OF THE PRODUCT, IT COULD NOT BE PULLED BACK INTO THE R2P DESTINATION SLENDER SHEATH. AFTER REINFLATION AND DEFLATION, REMOVAL WAS ATTEMPTED AGAIN, BUT RESISTANCE WAS FELT. AT THAT TIME, IT FELT AS IF THE SHAFT HAD STRETCHED AND BROKEN. A 7 FR SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY, AND THE PRODUCT WAS RETRIEVED USING AN EN SNARE (RETRIEVAL SNARE, MERIT MEDICAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421310 SENRI PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR045407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other