BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 8410812 · Received March 12, 2019

    Report

    Report Number
    3002808904-2019-00006
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 15, 2019
    Manufacturer
    KANEKA
    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. THE CONCERNED DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. 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. PROBABLE CAUSE(S) AND OUR COMMENT: THE BALLOON WAS INJURED BY THE HARD PART OF THE TARGETED LESION AND RUPTURED DURING BEING INFLATED. WHEN THE CATHETER WAS TRIED TO PULL OUT OUTSIDE THE PATIENT, THE BREAKAGE PART OF THE BALLOON WAS CAUGHT ON THE TIP OF THE GUIDING CATHETER OR THE TARGETED LESION, SO THE BALLOON WAS TORN OFF AND THE BROKEN FRAGMENT OF THE BALLOON WAS REMAINED INSIDE THE BLOOD VESSEL. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND, AND ACCORDINGLY, WE DETERMINE THAT THE EVENT REPORTED WAS CAUSED BY NOT ANY DEFECT OF THE DEVICE BUT THE USER'S HANDLING ISSUES.

    Description of Event or Problem · 1

    THE BALLOON EXPLODED INSIDE THE ARTERY AND THEREFORE PIECES OF THE BALLOON REMAIN IN THE PATIENT. NEED FOR A LAPAROTOMY AND GENERAL ANESTHESIA TO RECOVER THE PART OF THE SEVERED DEVICE THAT REMAINED IN THE PATIENT'S INTRA-LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204025 SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA SP098339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other