BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-35 6/100/130

    MDR report key: 2732175 · Received August 30, 2012

    Report

    Report Number
    1028232-2012-02165
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 15, 2012
    Manufacturer
    BIOTRONIK AG
    Product Code
    DQY
    PMA / PMN Number
    K082933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - A MODERATELY CALCIFIED PERIPHERAL ARTERIAL OCCLUSION WITH A STENOSIS DEGREE OF 80%, A VASCULAR DIAMETER OF 6 MM, AND A LENGTH OF 100 MM WAS TREATED. DURING DILATATION OF THE PASSEO-35, A BALLOON RUPTURE OCCURRED AT A PRESSURE OF 14 BAR, WHICH LED TO A RUPTURE OF THE VESSEL. THE VESSEL RUPTURE WAS SUCCESSFULLY TREATED WITH A COVERED STENT. THE PT WAS DISCHARGED FROM THE HOSPITAL WITHOUT FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSEO-35 6/100/130 BALLOON CATHETER DQY BIOTRONIK AG 357323 12114587

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization