BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANGSTON V2

    MDR report key: 6900588 · Received September 28, 2017

    Report

    Report Number
    2134812-2017-00073
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 22, 2017
    Report Date
    September 1, 2017
    Manufacturer
    VASCULAR SOLUTIONS, INC
    Product Code
    DQO
    UDI-DI
    M20655400
    PMA / PMN Number
    K051395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY CAUSE OF THE REPORTED EVENT, BASED ON THIS ANALYSIS IS THAT THE "INNER" BURST DURING HIGH PRESSURE INJECTION AND ALLOWED THE HIGH PRESSURE TO EXERT ON THE STRAIN RELIEF, CAUSING THE STRAIN RELIEF TO BURST AS WELL. ADDITIONAL INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MDR2134812-2017-000073. THIS DEVICE WAS RETURNED AND INVESTIGATED -(ALSO REFERENCE MDR-2134812-2017-00074, DEVICE DID NOT RETURN). EVALUATION OF THIS DEVICE CONFIRMED THE CATHETER STRAIN RELIEF TORE DURING USE. DISSECTION OF THE CATHETER REVEALED THAT THE INNER CATHETER HAD A LONGITUDINAL RUPTURE APPROXIMATELY 2.5 INCHES DISTAL TO THE STRAIN RELIEF, WHICH LIKELY OCCURRED DURING HIGH PRESSURE INJECTION AND RESULTED IN PRESSURE BUILD UP IN THE STRAIN RELIEF AREA UNTIL THE STRAIN RELIEF TORE. THE LOCATION OF THE LONGITUDINAL RUPTURE IS IN AN AREA OF THE INNER CATHETER WHERE NO FURTHER MANUFACTURING PROCESSES ARE PERFORMED. THE COMPONENT SUPPLIER INVESTIGATED THE RETURNED UNIT AND WAS UNABLE TO IDENTIFY A CAUSE FOR THE LONGITUDINAL RUPTURE. THE COMPONENT SUPPLIER PROVIDED TEST DATA FOR THE BURST PRESSURE OF THE INNER CATHETER SHAFTS SHOWING THAT THEIR PROCESS IS CAPABLE OF MEETING THE BURST PRESSURE REQUIREMENT. THE SUPPLIER DID NOT INDICATE ANY DEVIATIONS ON THIS LOT OR TREND OF SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING THE LV POWER INJECTION, THE YELLOW TUBING AT THE HUB OF THE CATHETER FRACTURED. 900 PSI WAS USED FOR THE INJECTION. ANOTHER LANGSTON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. REFERENCE MDR 2134812-2017-00074 FOR ASSOCIATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682365 LANGSTON V2 DUAL LUMEN DQO VASCULAR SOLUTIONS, INC 5540 604198 M20655400

    Patients

    Seq Age Sex Outcome Treatment
    1