BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 2/170/150

    MDR report key: 3434465 · Received October 29, 2013

    Report

    Report Number
    1028232-2013-03077
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Date of Event
    June 5, 2013
    Report Date
    October 14, 2013
    Manufacturer
    BIOTRONIK AG
    Product Code
    LIT
    PMA / PMN Number
    K072765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURED MARCH 2012. THE AFFECTED BALLOON REVEALED A LONGITUDINAL TEAR IN DISTAL DIRECTION; 24 MM IN LENGTH STARTING ABOUT. AT THE LEVEL OF THE PROXIMAL BALLOON MARKER. AT THE END OF THE TEAR THE BALLOON IS TRANSVERSAL FRACTURED. A SMALL PIECE OF THE BALLOON SURFACE IS MISSING. ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEW SHOWED NO DEVIATION IN MATERIAL OR MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    OUS MDR - THE BALLOON WAS PLACED IN THE SEVERELY CALCIFIED LESION OF THE LEFT ANTERIOR TIBIAL ARTERY. WHEN APPLYING 6 BAR THERE WAS NO FILLING OF THE BALLOON WITH CONTRAST MEDIUM. AFTER WITHDRAWING THE BALLOON A RUPTURE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553984 PASSEO-18 2/170/150 BALLOON CATHETER LIT BIOTRONIK AG 366137 03126190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization