BEUDAMED
    FDA Adverse Event Other Summary report: N

    032 REPERFUSION CATHETER

    MDR report key: 1532681 · Received November 17, 2009

    Report

    Report Number
    3005168196-2009-00107
    Event Type
    Other
    Date Received
    November 17, 2009
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE 032 REPERFUSION CATHETER WAS RETURNED WITH THE BALANCE OF ONE OF THE SEPARATORS LODGED IN IT. THE CATHETER HAD A SHARP SINGLE AXIS BEND AT THE END OF THE STRAIN RELIEF. AT 120CM FROM THE HUB/SHAFT JOINT THE CATHETER FLATTENED. THIS FLAT REGION EXTENDS TO THE DISTAL TIP OF THE CATHETER AND IN THE CLEAR REGION, SHOWS OBVIOUS EVIDENCE OF STRETCHING. THE INCIDENT WAS CONFIRMED AS REPORTED AND ALIGNS WITH THE PHYSICIANS STATEMENT THAT SHE MAY HAVE BEEN USING THE SYSTEM WITH TOO MUCH FORCE (CONCLUSION). CATHETER KINKS ARE REPORTABLE INCIDENTS AS PER FDA GUIDANCE ON (B)(4) 2009.

    Description of Event or Problem · 1

    PT HAD A CLOT AT THE M1/M2 TRANSITION. THE PHYSICIAN FIRST PLACED THE 070 NEURON BUT COULD NOT PLACE IT AS HIGH AS IT SHOULD HAVE BEEN DUE TO PT ANATOMY. THE PHYSICIAN THEN USED THE 032 SYSTEM ((B)(4)) TO RECANALIZE THE VESSEL. THE PHYSICIAN OBSERVED THE SEPARATOR FRACTURED AND THEN PLACED A SECOND SEPARATOR WHICH ALSO FRACTURED. SHE THEN DECIDED TO PULL THE ENTIRE 032 SYSTEM BACK AND REPLACED IT WITH THE 041 SYSTEM. THE 041 SYSTEM ALLOWED HER TO RECANALIZE SOME OF THE VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 032 REPERFUSION CATHETER SUBCUTANEOUS CATHETER NRY PENUMBRA, INC. F15210

    Patients

    Seq Age Sex Outcome Treatment
    1