BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI EX

    MDR report key: 15161925 · Received August 4, 2022

    Report

    Report Number
    3002808904-2022-00008
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 11, 2022
    Report Date
    July 13, 2022
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: WHEN THE CONCERNED DEVICE WAS EXPANDED WITH RBP, IT WAS CONFIRMED THAT THE BALLOON LENGTH WAS 158MM AND THE OUTER DIAMETER WAS 5.43MM. WE WERE UNABLE TO CONFIRM ANY ABNORMALITIES SUCH AS STRETCHING IN THE CONCERNED DEVICE. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DEVICE HISTORY RECORDS (DHR). IN ADDITION, NO STRETCHING ABNORMALITY WAS CONFIRMED IN THE INVESTIGATION OF THE CONCERNED DEVICE, AND NO ABNORMALITY CAUSED BY THE MANUFACTURING PROCESS OR DESIGN WAS IDENTIFIED. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    FOR THE SFA LESION, WHEN THE CONCERNED DEVICE WAS EXPANDED WITH RBP, THE BALLOON IN THE SFA WAS ELONGATED PROXIMAL DIRECTION. BLEEDING OCCURRED DISTAL TO THE SFA, ALTHOUGH THE CAUSALITY OF BALLOON DILATATION IS UNKNOWN. HEMOSTASIS WAS ACHIEVED BY DILATION WITH DCB FOR ABOUT 3 MINUTES. THERE IS ALSO SUSPICION OF A FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704923 SENRI EX PTA BALLOON DILATATION CATHETER, PRODUCT CODE: LIT LIT KANEKA CORPORATION SR111331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other