BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST INFLATION DEVICE 30ATM

    MDR report key: 4173238 · Received October 15, 2014

    Report

    Report Number
    1220452-2014-00064
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    January 7, 2015
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DTL
    PMA / PMN Number
    K960983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (INCONCLUSIVE, INVESTIGATION IN PROGRESS). (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: CONFIRMED FOR LEAK. CONCLUSION: NO ROOT CAUSE CAN BE DETERMINED. THE DEVICE WAS PREPPED PRIOR TO USE WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AIR LEAKING OCCURRED WITH AN EVEREST INFLATION DEVICE WHEN NEGATIVE PRESSURE WAS APPLIED DURING INFLATION OF A STENT AT THE TARGET LESION. NO ABNORMALITIES WERE NOTED DURING DEVICE INSPECTION AND PREPARATION BEFORE THE OPERATION. THE EVEREST DEVICE WAS CONNECTED TO THE STENT DEVICE VIA A Y-ADAPTOR. THE PHYSICIAN STOPPED USING THE RELEVANT DEVICE AND USED A NEW EVEREST INFLATION DEVICE WITH THE SAME Y ADAPTOR TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: RECEIVED FOR EVALUATION WAS ONE AC3200 EVEREST DEVICE WITHOUT ORIGINAL PACKAGING. RESIDUAL CONTRAST WAS PRESENT IN THE BARREL OF THE SYRINGE DENOTING USE. THE DEVICE WAS RECEIVED WITH A STOPCOCK ENGAGED TO THE EXTENSION LINE. NO INITIAL VISUAL DAMAGE WAS DETECTED ON THE DEVICE. DURING INITIAL TESTING WATER WAS ASPIRATED INTO THE BARREL RESULTING IN A DETECTED LEAK THRU THE RUBBER OF THE PLUNGER. THE NEEDLE WENT UP UNDER PRESSURE TO 30ATM AND THEN SUDDENLY DROPPED TO 12ATM MOST LIKELY DUE TO THE DETECTED LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655621 EVEREST INFLATION DEVICE 30ATM ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL MEDTRONIC, INC 50805986

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR