BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YAMATO PLUS-R 7.5FR. 40CC IAB

    MDR report key: 8864150 · Received August 6, 2019

    Report

    Report Number
    2248146-2019-00646
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 5, 2019
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WAS PERFORMED. THE NEXT DAY, INTRA-AORTIC BALLOON (IAB) THERAPY WAS STARTED. LATER ON, AS ATRIAL FIBRILLATION (AF) APPEARED, DEFIBRILLATION WAS PERFORMED AT 150 JOULES FOR THE TREATMENT. WHEN THE REPORTED SHUTDOWN ISSUE OCCURRED, THE POWER WAS STILL ON, THE CONSOLE WAS TURNED OFF AND TURNED ON AGAIN TO START DRIVING. THE ISSUE WAS RESOLVED AFTER REBOOTING OF THE PUMP. LATER ON IN THE DAY, THE CONSOLE WAS REPLACED BY THE PHYSICIAN'S JUDGEMENT. THE FOLLOWING DAY, THE IAB CATHETER WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS RELEASED FROM THE IABP THERAPY. IT WAS REPORTED THAT THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY AND THERE WAS NO FURTHER ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO REPORTED MALFUNCTION ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658125 YAMATO PLUS-R 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other