BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2893729 · Received January 2, 2013

    Report

    Report Number
    3005168196-2013-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE ARE NO KINKS OF VISIBLE DAMAGE ON THE CATHETER. CONCLUSION: THE BEHAVIOR OF THE GUIDE WIRE INSIDE OF THE CATHETER NOTED IN THE COMPLAINT WAS CONFIRMED. THE BENT TIP OF THE GUIDE WIRE TRACKS ALONG THE SIDE WALL OF THE PROXIMAL SHAFT AND CATCHES ON THE LIP OF THE DISTAL SHAFT. AS THE GUIDE WIRE ADVANCES IT IS SOFT ENOUGH TO FOLD OVER ON ITSELF AND JAM IN THE DISTAL SECTION OF THE SHAFT. IF THE TIP OF THE GUIDE WIRE IS SHAPED, THE PHYSICIAN MAY EXPERIENCE DIFFICULTY TRACKING IT THROUGH THE CATHETER. THE CATHETER IN THIS CASE HAD NO MALFUNCTION OR DEFECT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO INSERT THE GUIDE WIRE (CHIKAI 14) INTO THE PSC032 WITH RESISTANCE OUTSIDE OF THE PATIENT'S BODY AND FAILED IN INTRODUCING. THE PHYSICIAN CONCLUDED THE PROCEDURE WITH ANOTHER NEW PSC032 OPENED AFTERWARDS WITH NO PROBLEM DUE TO TORQUE EMPLACEMENT ALTHOUGH IT WAS FIRST TRICKY TO PASS THROUGH. THE PATIENT'S BLOOD VESSEL WAS TORTUOUS AND ASPIRATION WITH THE PSC054 FAILED. THE PHYSICIAN INDUCED THE PSC032 INTO THE VESSEL FOR ASPIRATION BUT THE ANGIOGRAPHY REVEALED RECANALIZATION. NO ASPIRATION HAD DONE BUT RESULTED IN RECANALIZATION OF TICI3. MRS SCORE BEFORE THE PROCEDURE: 3, AFTER THE PROCEDURE; 4. THE PATIENT HAVE EXPERIENCED RIGHT-HEMIPLEGIA AND APHASIA BEFORE AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F26330

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR