BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 21822867 · Received April 11, 2025

    Report

    Report Number
    3002808904-2025-00012
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 13, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED 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) THE BALLOON COMPONENT WAS FOUND TO BE FRACTURED TOGETHER WITH THE TIP AT APPROXIMATELY 68 MM FROM THE DISTAL END. THE DISTAL SEGMENT OF THE INNER SHAFT EXHIBITED ELONGATION OF APPROXIMATELY 53 MM. THE BROKEN BALLOON PIECE ON THE DISTAL SIDE WAS NOT RETURNED. FURTHERMORE, A LONGITUDINAL RUPTURE OF THE BALLOON WAS OBSERVED OVER A REGION SPANNING APPROXIMATELY 68 MM TO 80 MM FROM THE DISTAL END. 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 RESIDUAL FRAGMENTS WERE RETRIEVED FROM THE PATIENT'S BODY, AND NO CLINICAL IMPACT ON THE PATIENT HAS BEEN REPORTED. HOWEVER, BECAUSE FINAL PROCEDURAL DETAILS RELATED TO THE RETRIEVAL OF THE FRACTURED FRAGMENT COULD NOT BE OBTAINED, THE POSSIBILITY OF A SERIOUS INJURY CANNOT BE ENTIRELY RULED OUT. BASED ON THE INVESTIGATION, IT IS PRESUMED THAT THIS WAS A PROCEDURE-RELATED EVENT. A LONGITUDINAL RUPTURE LIKELY OCCURRED WHEN THE BALLOON WAS EXPANDED IN A SHARP OR HEAVILY CALCIFIED LESION. SUBSEQUENTLY, DURING DEVICE REMOVAL, THE RUPTURED SECTION MAY HAVE CAUGHT ON THE TIP OF THE GUIDING SHEATH AND WAS SUBJECTED TO EXCESSIVE TRACTION, RESULTING IN THE FRAGMENTATION. THEREFORE, IT WAS CONCLUDED THAT THERE WERE NO ISSUES RELATED TO THE PRODUCT'S DESIGN OR MANUFACTURING.

    Description of Event or Problem · 0

    THE BALLOON BROKE IN 2 WITHIN THE PATIENT. NO CLINICAL CONSEQUENCES FOR THE PATIENT AT THE MOMENT OF DECLARATION. THE TOTALITY OF THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104024 SENRI PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR064199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other