BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 21973609 · Received May 6, 2025

    Report

    Report Number
    3002808904-2025-00015
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    November 15, 2024
    Report Date
    April 11, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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) THERE WAS NO RETURN OF THE DEVICE. 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: THERE WAS NO RETURN OF THE DEVICE, IT CANNOT BE DEFINITIVELY CONFIRMED THAT IT WAS THE PROTECTIVE MATERIAL OF THE DEVICE. HOWEVER, SINCE THE PATIENT PROGRESSED FROM ISCHEMIA TO AMPUTATION, THE EVENT HAS BEEN ASSESSED AS A SERIOUS ADVERSE HEALTH OUTCOME. BASED ON CIRCUMSTANTIAL EVIDENCE, IT IS HIGHLY LIKELY THAT THE PROCEDURE WAS PERFORMED WITH THE PROTECTIVE MATERIAL LEFT IN PLACE, AND THAT THE MATERIAL WAS UNINTENTIONALLY RETAINED IN THE BODY DUE TO PROCEDURAL FACTORS. THEREFORE, THE EVENT IS CONSIDERED TO BE PROCEDURE-RELATED, AND NO ISSUES HAVE BEEN IDENTIFIED WITH THE PRODUCT'S DESIGN OR MANUFACTURING.

    Description of Event or Problem · 0

    CLI PATIENT WITH ACUTE LIMB FOR PTA INTERVENSION BELOW THE KNEE VESSELS. A SENRI PTA WAS USED. FOLLOWING PROCEDURE PATIENTS LEG BECAME ISCHAEMIC AND ENDED UP WITH AN AMPUTATION. INVESITIGATION HAS FOUND THAT THE SENRI PTA OVER SHEATH WAS INTRODUCED AND LEFT IN PATIENTS LEG CONTRIBUTING TO CRITICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871765 SENRI PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR014112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention