BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 9736368 · Received February 20, 2020

    Report

    Report Number
    3002808904-2020-00004
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 23, 2020
    Report Date
    January 24, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. SINCE THE ACTUAL DEVICE WAS NOT RETUNED, WE INVESTIGATED THE DEVICE HISTORY RECORDS. 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 VISUAL TEST, 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. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DHR. WE BELIEVE THE REPORTED PROBLEM WOULD NOT BE CAUSED BY ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    EXPANSION BALLOON DETACHED AND GOT STUCK ON THE GUIDE. INCIDENTAL DISCOVERY DURING THE INCISION OF THE ARTERY TO PERFORM BYPASS SURGERY. AS CONCLUSION, THE BALLOON REMAINED INTO THE ARTERY BUT THE PHYSICIAN WAS NOT ABLE TO EXPLAIN HOW AS HE DID NOT NOTIFY THE MISSING BALLOON AT THE END OF THE PROCEDURE. THE REMAINING BALLOON WAS DISCOVERED DURING PLANNED BYPASS SURGERY AND REMOVED. THIS BYPASS SURGERY WOULD NOT PERFORMED TO REMOVE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199276 SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA CORPORATION SP108513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other