BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2893728 · Received January 2, 2013

    Report

    Report Number
    3005168196-2013-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 30, 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 ITS SELF 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. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-0004.

    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. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN FELT RESISTANCE WHEN INSERTING GT WIRE INTO THE PSC032 OUTSIDE OF THE BODY FOR A TEST. ANOTHER PSC032 FROM DIFFERENT LOT WAS TRIED BUT WAS WITH RESISTANCE AS WELL. THE PHYSICIAN FINISHED THE PROCEDURE WITH ANOTHER NEW PSC032 FROM DIFFERENT LOT. THE PHYSICIAN USED TWO GUIDE WIRES BECAUSE THEY COULDN'T BE INSERTED. KINKS WERE CONFIRMED ON BOTH OF THE GUIDE WIRES; THEREFORE, INSIDE OF THE PSC032 MIGHT HAVE BEEN STRETCHED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00004.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR