BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR FLEX 032

    MDR report key: 2102837 · Received April 12, 2011

    Report

    Report Number
    3005168196-2011-00212
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 15, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA SYSTEM SEPARATOR FLEX (B)(4) PROXIMAL END IS BROKEN APPROX 7.0 CM DISTAL OF THE PROXIMAL END OF THE PTFE COATING. THE DISTAL SIDE OF THE FRACTURE IS NOT VISIBLE IN THE CATHETER HUB. THE BULB STRUCTURE OF THE SEPARATOR TIP IS LODGED APPROX 3.5 CM FROM THE DISTAL TIP OF THE CATHETER. THERE ARE SOME MINOR FLAT SPOTS IN THE CATHETER PROXIMAL TO THE SEPARATOR BULB. TO EXPOSE THE DISTAL END OF THE BROKEN SEPARATOR, THE CATHETER WAS CUT APPROX 2 CM DISTAL OF THE HYPOTUBE STRAIN RELIEF. THE EXPOSED END OF THE SEPARATOR SHOWS A 2.0 CM PROLAPSE SECTION. ONCE THE PROXIMAL SECTION OF THE CATHETER WAS CUT BACK FROM THE PROLAPSED SEPARATOR WIRE, THE SEPARATOR MOVED FREELY THROUGH THE TIP OF THE CATHETER. THE SEPARATOR AND CATHETER ARE NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT WAS CONFIRMED AS REPORTED. MOST OF THE FLAT SPOTS SEEN IN THE CATHETER APPEAR TO BE POST PROCEDURE HANDLING DAMAGE AND DO NOT APPEAR TO HAVE AFFECTED THE USE OF THE SEPARATOR. THE CAUSE OF THE PROLAPSED SECTION IN THE WIRE MAY BE RELATED TO THE HARD CLOT DESCRIBED IN THE COMPLAINT. IF THE SEPARATOR IS USED TO BREAK UP HARD CLOT, THE ADDITIONAL FORCE MAY HAVE PUT PROXIMAL COMPRESSION ON THE SEPARATOR WIRE CAUSING THE WIRE TO KINK AND EVENTUALLY BREAK.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A PENUMBRA SYSTEM SEPARATOR FLEX (B)(4) INSIDE A PENUMBRA SYSTEM REPERFUSION CATHETER (B)(4) WHEN THE SEPARATOR SEEMED TO GET STUCK IN THE CATHETER. UPON ATTEMPTING TO REMOVE THE SEPARATOR, IT BROKE OFF AND WAS STUCK INSIDE THE CATHETER. THE PHYSICIAN NOTED THE CLOT WAS HARD AND DIFFICULT TO REMOVE IN THE PT. THE PROCEDURE WAS TERMINATED. THE PT CONDITION IS UNK. ADDITIONAL ATTEMPTS TO GET MORE INFO FROM THE HOSPITAL WERE UNSUCCESSFUL. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00213.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR FLEX 032 NRY PENUMBRA, INC. F17098

    Patients

    Seq Age Sex Outcome Treatment
    1