BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 DETACHMENT HANDLE

    MDR report key: 2970654 · Received February 20, 2013

    Report

    Report Number
    3005168196-2013-00066
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 21, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DETACHMENT HANDLE LOOKS TO BE IN ITS ORIGINAL CONDITION. THE HANDLE WAS OPENED AND THERE WAS NO BLACK TUBING STUCK INSIDE THE HANDLE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND COULD NOT BE CONFIRMED. THE INVESTIGATOR IN THIS COMPLAINT MENTIONS HE TRIED THREE TIMES TO DETACH THE COIL AND WAS UNSUCCESSFUL. THE HANDLE WAS TESTED AND FUNCTIONED AS EXPECTED DURING TESTING. THE HANDLE PASSED THE SPECIFICATIONS REQUIRED FOR COIL DETACHMENT. THE CAUSE OF THIS FAILURE CANNOT BE DETERMINED. THIS ISSUE DOES NOT APPEAR TO HAVE BEEN DUE TO A DETACHMENT HANDLE FAILURE AND WAS LIKELY CAUSED BY A PROCEDURAL TECHNIQUE ISSUE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00065.

    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

    AFTER INITIAL PLACEMENT OF THE FIRST PC 400 COIL INTO THE ANEURYSM, THE SECOND COIL HAD A DETACHMENT PROBLEM AND COULD NOT BE DETACHED WITH THE HANDLE (LOT NUMBER F24712). THE INVESTIGATOR REPORTED HE TRIED TO DETACH IT THREE TIMES WITHOUT SUCCESS, AND THEN SWITCHED TO MANUAL DETACHMENT. THERE WERE NO PATIENT ADVERSE EVENTS LINKED TO THE DETACHMENT PROBLEM AND THE INVESTIGATOR WAS ABLE TO CONTINUE TREATMENT WITH A NEW DETACHMENT HANDLE WITH NO ADDITIONAL PROBLEMS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74583 PENUMBRA COIL 400 DETACHMENT HANDLE HCG, KRD KRD PENUMBRA, INC. F24712

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR