BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 5446046 · Received February 18, 2016

    Report

    Report Number
    3005168196-2016-00194
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    January 19, 2016
    Report Date
    January 20, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011370
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-00193, 2. 3005168196-2016-00195, 3. 3005168196-2016-00196, 4. 3005168196-2016-00197, 5. 3005168196-2016-00198.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PENUMBRA COIL 400 (PC400) WAS RETURNED INSIDE ITS STERILE POUCH, WRAPPED-UP AND TAPED TOGETHER, INSIDE A SPECIMEN BAG. THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PC400 PUSHER ASSEMBLY. THE PC400 PUSHER ASSEMBLY WAS KINKED IN MULTIPLE LOCATIONS ALONG THE PUSHER ASSEMBLY; THE STRETCH RESISTANT WIRE (SR WIRE) WAS FRACTURED AND THE PROXIMAL CONSTRAINT SPHERE REMAINED INTACT WITH THE DISTAL DETACHMENT TIP (DDT) ON THE DISTAL END OF THE PUSHER ASSEMBLY. THE PC400 EMBOLIZATION COIL WAS NOT RETURNED FOR EVALUATION AND, THEREFORE, NO DIMENSIONAL MEASUREMENTS WERE TAKEN. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE PX SLIM WAS DAMAGED. IT IS LIKELY THAT THE OBSERVED DAMAGE TO THE PX SLIM WAS SUSTAINED DUE TO THE PACKAGING TRAY BEING CLOSED AND PINCHED ONTO THE DEVICE. EVALUATION OF THE RETURNED PC400 COMPONENTS REVEALED MULTIPLE KINKS ALONG THE ENTIRE PUSHER ASSEMBLY. THE DAMAGE FOUND ON THE PUSHER ASSEMBLY WAS LIKELY INCIDENTAL AND MAY HAVE OCCURRED DURING PACKAGING FOR RETURN. FURTHER EVALUATION OF THE PC400 REVEALED THAT THE SR WIRE WAS FRACTURED, AND CONFIRMED THAT THE EMBOLIZATION COIL WAS MISSING. FRACTURE OF THE PC400 SR WIRE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. SINCE THE EMBOLIZATION COIL WAS NOT RETURNED FOR EVALUATION, NO DIMENSIONAL MEASUREMENTS COULD BE TAKEN. DUE TO THE INABILITY TO PERFORM A DIMENSIONAL ANALYSIS, AND THE DAMAGE SUSTAINED BY THE PC400 PUSHER ASSEMBLY AND PX SLIM DURING PACKAGING FOR RETURN, THE CAUSE OF THE INITIAL RESISTANCE EXPERIENCED BY THE PHYSICIAN COULD NOT BE DETERMINED. NEITHER OF THE DETACHMENT HANDLES MENTIONED IN THE INITIAL REPORT, NOR THE PC400S USED WITH THESE DETACHMENT HANDLES WERE RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE DIFFICULTY DETACHING THESE PC400S COULD NOT BE DETERMINED. PX SLIMS ARE 100% VISUALLY INSPECTED DURING PROCESS INSPECTION. PC400S AND DETACHMENT HANDLES ARE 100% FUNCTIONALLY TESTED DURING INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE PHYSICIAN CONSIDERED THE ANEURYSM TO HAVE BEEN PROPERLY FILLED WITH THE TWO PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103006 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F63825 00814548011370

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR