BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 4200304 · Received October 24, 2014

    Report

    Report Number
    3005168196-2014-00778
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 26, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5X9 PC400 COIL WAS STILL INTACT WITH THE PUSHER ASSEMBLY. THE PET-LOCK ON THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS ALSO INTACT. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 15.0 AND 122 CM FROM THE PROXIMAL END. THE 5X13 PC400 COIL WAS INTACT WITH THE PUSHER ASSEMBLY. THE PET-LOCK WAS STILL INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE COIL INTRODUCER SHEATH WAS OVALIZED APPROXIMATELY 7.0 CM FROM THE DISTAL TIP. THE EXTRA COIL INTRODUCER SHEATH WAS DAMAGED APPROXIMATELY 6.0 CM FROM THE PROXIMAL END. THE DISTAL SHAFT OF THE PUSHER ASSEMBLY HAD A SHAPE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE 5X9 AND 5X13 PC400 COILS COULD NOT MOVE FROM THEIR INTRODUCER SHEATHS. EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE 5X9 PC400 COIL PUSHER ASSEMBLY WAS KINKED IN TWO LOCATIONS. THE COIL WAS RETRACTED INTO THE INTRODUCER SHEATH AND ADVANCED DISTALLY WITHOUT AN ISSUE; HOWEVER THE KINKS ALONG THE HYPO-TUBE SHAFT PREVENTED COIL FROM BEING INTRODUCED IN A MICROCATHETER. THE 5X13 PC400 COIL INTRODUCER SHEATH WAS OVALIZED IN THE DISTAL AREA. THIS OVALIZATION PREVENTED THE COIL FROM ADVANCING DISTALLY OUT OF THE INTRODUCER SHEATH. BASED ON THE DESCRIPTION OF THE EVENT AND EVALUATION, IT APPEARS A ROTATING HEMOSTATIC VALVE (RHV) MAY HAVE BEEN OVER-TIGHTEN ON THE LUMEN OF THE INTRODUCER SHEATH. THE PENUMBRA COIL 400 DEVICES ARE 100% FUNCTIONAL TESTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00734.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO PENUMBRA COIL'S 400 FROM THEIR INTRODUCER SHEATHS. THE PHYSICIAN COMPLETED THE PROCEDURE USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680099 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F41403

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR