BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANGSTON V2

    MDR report key: 6911531 · Received October 3, 2017

    Report

    Report Number
    2134812-2017-00076
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 5, 2017
    Manufacturer
    VASCULAR SOLUTIONS, INC
    Product Code
    DQO
    PMA / PMN Number
    K051395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RELATED TO MDR 2134812-2017-00090 LANGSTON V2 AND MDR 2134812-2017-00091 LANGSTON V2. THE RETURNED PRODUCT EVALUATION CONFIRMED THE HUB OF THE CATHETER WAS SEPARATED FROM THE STRAIN RELIEF. A LEAK TEST WAS PERFORMED ON THE RETURNED UNIT AND THE RESULTS SHOW THAT INJECTING THROUGH THE AO (AORTIC) PORT PRODUCED A LEAK AT THE POINT OF SEPARATION, BETWEEN THE PROXIMAL HUB/STRAIN RELIEF BOND. FURTHERMORE, A LIQUID LEAKAGE UNDER PRESSURE TEST WAS COMPLETED ON TEST UNITS. TEST RESULTS CONCLUDED THAT THE MOST LIKELY ROOT CAUSE FOR THIS FAILURE IS THAT A HIGH PRESSURE INJECTION WAS ATTEMPTED THROUGH THE AO PORT CAUSING THE BOND TO SEPARATE. THE LANGSTON IFU PRECAUTIONS; "DO NOT USE THE OUTER LUMEN FOR THE DELIVERY OR INFUSION OF DIAGNOSTIC, EMBOLIC, THERAPEUTIC MATERIALS OR TO PERFORM PRESSURE INJECTIONS OF CONTRAST MEDIUM INTO THE VASCULAR SYSTEM AS SUCH PRESSURE INJECTIONS COULD RESULT IN DEVICE DAMAGE."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION IS IN PROGRESS BY SUPPLIER. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    LEAKING AT THE END OF THE CASE CLOSE TO THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691973 LANGSTON V2 DUAL LUMEN DQO VASCULAR SOLUTIONS, INC 5540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1