BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON MICRO CATHETER

    MDR report key: 2981340 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00181
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 1, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ONLY THE PROXIMAL BROKEN SEGMENT OF THE CATHETER WAS RETURNED. EVALUATION SHOWED THE CATHETER BROKE DUE TO A TENSILE FORCE APPLIED DURING USE.CATHETER SEPARATION.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM (ARTERIOVENOUS MALFORMATION). DURING ONYX INJECTION, IT WAS REPORTED THAT THE PHYSICIAN HAD A DIFFICULT TIME VISUALIZING THE ONYX AS IT CAME OUT OF THE MARATHON CATHETER AND THE CATHETER BECAME ENTRAPPED. THE DISTAL TIP OF THE CATHETER SEPARATED DURING RETRIEVAL AND REMAINED IN THE PATIENT UNTIL THE EXCISION SURGERY IN WHICH IT WAS REMOVED WITH THE ONYX CAST.SAME EVENT AS MDR# 2029214-2013-00181.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84517 MARATHON MICRO CATHETER FLOW-DIRECTED MICRO CATHETER DYG EV3 NEUROVASCULAR 105-5055 9680614

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability