BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE DILATATION

    MDR report key: 4551520 · Received February 20, 2015

    Report

    Report Number
    MW5040921
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    February 10, 2015
    Report Date
    February 20, 2015
    Manufacturer
    LOMA VISTA MEDICAL
    Product Code
    OZT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE WITH THE BALLOON CATHETER WAS INSERTED THE BALLOON REWRAPPER WAS NOT HELD BACK, AND WAS UNKNOWINGLY INTRODUCTED WITH THE BALLOON. ONCE IN PLACE THE BALLOON WOULD NOT INFLATE, MEASURES TAKEN TO INFLATE, DID NOT WORK SO REMOVED (BALLOON WRAPPER STAYED IN THE PT). WHEN THE NEXT BALLOON WAS USED AFTER THE FACT IT IS SUSPECTED THE REWRAPPER WAS PUSHED FURTHER INTO THE PT. THE BALLOON REWRAPPER IS CLEAR LIKE A STRAW WITH NO COLORING, MARKINGS, OR FLUTED ENDS LIKE OTHER BALLOONS THAT WOULD BRING TO THE ATTENTION OF THE USER THEY MAY HAVE FORGOTTEN TO HOLD THIS BACK ON THE SHAFT WHILE INSERTING THE BALLOON. PT DID WELL AFTER THE PROCEDURE BUT THEN DEVELOPED STROKE LIKE SYMPTOMS. STROKE CALL (B)(6) 2015, CT OF HEAD/NECK SHOWED NO ACUTE SIGNS OF INTRACRANIAL PROCESS, SYMPTOMS CONTINUE WITH MEASURE OF TREATMENT AND CONDITION NOT IMPROVING, (B)(6) 2015 - CT OF THE CHEST REVEALS RETAINED TUBULAR FOREIGN BODY WITHIN THE ASCENDING AORTA, TIP SUPERIORLY IN THE BRACHIOCEPHALIC ARTERY. REMOVED (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122089 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER OZT LOMA VISTA MEDICAL 02045-11 PLN02802

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening