BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 19717810 · Received July 11, 2024

    Report

    Report Number
    3002808904-2024-00005
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 4, 2024
    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 "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018"GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. 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 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. CAUSE INVESTIGATION AND CONCLUSION; BASED ON THE LOT NUMBER, THE DEVICE HISTORY RECORD (DHR) OF THE DEVICE WAS NO PROBLEM, AND WE INFERRED THAT THE EVENT WAS LESION-INDUCED AND PROCEDURE-INDUCED DUE TO EXCESSIVE PULLING DUE TO STUCK IN THE LESION OR COMBINED DEVICES AFTER BALLOON RUPTURE, THEREFORE, WE DETERMINED THAT THE MANUFACTURING AND DESIGN OF THE DEVICE WERE NOT A PROBLEM.

    Description of Event or Problem · 0

    DURING A FEMOROPOPLITEAL BYPASS OPERATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES WITH LOSS OF THE DISTAL PART, WHICH HAD COMPLETELY SEPARATED FROM THE CARRIER. THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE FOR A HEMORRHAGIC SHOCK: THE BALLOON REMAINED STUCK IN THE RIGHT FEMORAL ARTERY, AND SHE PRESENTED A SIGNIFICANT HEMATOMA OF THE LEFT SCARPA. NEED FOR CORRECTIVE SURGERY TO RECOVER THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315381 SENRI SENRI ¿ BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR103675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other