BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOUE BALLOON CATHETER

    MDR report key: 8742091 · Received June 27, 2019

    Report

    Report Number
    9612812-2019-00001
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    TORAY INDUSTRIES, INC.
    Product Code
    MAD
    UDI-DI
    14960685200030
    PMA / PMN Number
    P910054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF OUR INVESTIGATION INTO THE ACTUAL DEVICE RETURNED FROM THE MEDICAL INSTITUTION, IT WAS FOUND OUT THAT THE LOT NO. WAS 190124 AND THERE WERE NO PROBLEMS OBSERVED WITH THE MANUFACTURING RECORD OR AT THE TIME OF SHIPMENT. NO ABNORMALITY OF THE DEVICE WAS DETECTED AS A RESULT OF THE INVESTIGATION INTO THE RETURNED DEVICE.

    Description of Event or Problem · 1

    PATIENT SUSTAINED, WHAT INITIALLY APPEARED TO BE, A CHORD RUPTURE AFTER 2ND INFLATION AT 23MM. SEPTAL CROSSING WAS IN PROPER LOCATION WITH UNCOMPLICATED CROSSING OF MITRAL VALVE ON BOTH INFLATION ATTEMPTS, NO EMPASSE SIGN NOTED. AFTER INFLATION SEVERE CONCENTRIC MR JET NOTED ON ECHO WITH TEMPORARY DROP IN PATIENT'S PAO2. PT'S BP, SATS, WERE STABLE WITHOUT ADDITIONAL INTERVENTION. SURGICAL CONSULT COMPLETED AND PATIENT TAKEN TO OR FOR VALVE REPLACEMENT. PT'S CORONARIES WERE ASSESSED PRIOR TO SURGERY AND RIGHT MAIN WAS OCCLUDED RESULTING IN A SURGICAL PLAN OF MV REPLACEMENT, GRAFTING FOR OCCLUSION, CLIPPING OF ATRIAL APPENDAGE AND ABLATION FOR AFIB. INITIAL ASSESSMENT FOR PATIENT FOR SURGICAL INTERVENTIONS ARE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534402 INOUE BALLOON CATHETER CATHETER, PERCUTANEOUS (VALVULOPLASTY) MAD TORAY INDUSTRIES, INC. 190124 14960685200030

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R