BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PX400 MICROCATHETER

    MDR report key: 3160264 · Received June 10, 2013

    Report

    Report Number
    3005168196-2013-00215
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 15, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGES ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00418. A PRODUCT PROBLEM FOR THIS EVENT WAS INITIALLY REPORTED WITH MDR 3005168196-2012-00418. THE ADVERSE EVENT IN THIS MDR WAS NOT LINKED TO THIS PATIENT UNTIL (B)(4) 13. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING TREATMENT TOR COIL EMBOLIZATION OF LEFT ICA ANEURYSM. PX SLIM MICROCATHETER USED TO ACCESS THE ANEURYSM. UPON PLACEMENT OF THREE COILS THE MICROCATHETER WAS KICKED OUT. PHYSICIAN CONTINUED ATTEMPTS AT ACCESSING THE ANEURYSM. HE THEN SAW DYE EXTRAVASATION COMING OFF THE LEFT SIDE OF A1, RESULTING IN A SUBARACHNOID HEMORRHAGE. THE PERFORATED A1 VESSEL AND UNTREATED LOBES OF THE ANEURYSM WERE OCCLUDED WITH SIX MORE COILS, WHICH LEAD TO COMPLETE EMBOLIZATION WITH NO FURTHER EVIDENCE OF DYE EXTRAVASATION. THE PATIENT BECAME VERY SLEEPY AND LETHARGIC. HYDROCEPHALUS WAS NOTED IN HER FRONTAL LOBE SO AN EMERGENT VENTRICULOSTOMY WAS PLACED IN THE RIGHT FRONTAL AREA. SHE WAS THEN INTUBATED AND PLACED ON A VENTILATOR. PATIENT WAS HOSPITALIZED FOR TWO WEEKS AND RELEASED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260584 PX400 MICROCATHETER DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R