BEUDAMED
    FDA Adverse Event Summary report: N

    TRELLIS 8 120X30

    MDR report key: 2982663 · Received February 28, 2013

    Report

    Report Number
    2953189-2013-00026
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 30, 2013
    Manufacturer
    EV3 INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER IS UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DVT ACCESSED POPLITEAL VEIN: THE CUSTOMER STATES THAT WHEN YOU INFUSE THROUGH INFUSION PORT, THE DISTAL BALLOON INFLATED. THE BALLOON WAS INFLATED UNTIL IT BURST. NO INJURY TO THE PATIENT OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88682 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLUSH KRA EV3 INC. BVT812030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other