BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLOW HPC 1.5F

    MDR report key: 1662676 · Received April 16, 2010

    Report

    Report Number
    2029214-2010-00067
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 17, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SECTION OF THE CATHETER WAS RETURNED FOR EVAL WITH APPROXIMATELY 20 CM OF THE DISTAL SEGMENT MISSING. THE AMOUNT OF ONYX (LIQUID EMBOLIC) REFLUX WAS REPORTED TO BE 1.5-2 CM (PER IFU WARNING, "DO NOT ALLOW MORE THAN 1 CM OF ONYX TO REFLUX BACK OVER CATHETER TIP.") WHEN THE AMOUNT OF REFLUX IS GREATER THAN 1 CM, THIS CAN LEAD TO CATHETER TIP ENTRAPMENT AND DURING WITHDRAWAL, CATHETER SEPARATIONS CAN RESULT. RESULTS - CATHETER SEPARATION. (B) (4)

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THE AVM WAS TREATED WITH ONYX THROUGH THE ULTRAFLOW CATHETER WITH APPROX 1.5-2CM OF ONYX REFLUX. UPON CATHETER REMOVAL, THE PHYSICIAN NOTICE HIGHER FORCE REQUIRED AND STOPPED. ANOTHER ATTEMPT WAS MADE WHICH WAS NOT POSSIBLE AS THE PT EXPERIENCED VASOSPASM AND THE PT WAS ADMINISTERED NIMOTOP. A MICROSNARE WAS USED TO SUPPORT PULL BACKED THE CATHETER. IT WAS REPORTED THE CATHETER BROKE OFF 20CM FROM THE DISTAL TIP. THE BROKEN SEGMENT REMAINED IN THE PT. IT WAS REPORTED THE PT HAD A BLEED ON THE NIGHT OF THE PROCEDURE AND ANOTHER BLEED ON THE FOLLOWING DAY. TWO DAYS AFTER, THE PT EXPIRED. SAME EVENT AS MDR#2029214-2010-00068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC 1.5F FLOW-DIRECTED MICRO CATHETER KRA EV3 NEUROVASCULAR 105-5065 7944580

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death