BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 10467138 · Received August 28, 2020

    Report

    Report Number
    3005168196-2020-01320
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 3, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THERE WAS NO VISIBLE DAMAGE TO THE RETURNED HANDLE. CONCLUSIONS: EVALUATION OF THE RETURNED SMART COIL REVEALED A BROKEN PET LOCK AND A DETACHED EMBOLIZATION COIL. IF THE PET LOCK IS BROKEN AND THE PULL WIRE IS RETRACTED OUT OF THE DDT, THE EMBOLIZATION COIL WILL DETACH FROM ITS PUSHER ASSEMBLY. THE DETACHED EMBOLIZATION COIL WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURNED CONDITION, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. EVALUATION OF THE RETURNED HANDLE REVEALED A FUNCTIONAL DEVICE. DURING THE FUNCTIONAL TEST, THE HANDLE WAS TESTED ON THE HANDLE TEST FIXTURE AND PASSED WITHIN SPECIFICATION. THE HANDLE WAS THEN USED TO DETACH A DEMONSTRATION SMART COIL WITHOUT AN ISSUE. PENUMBRA COILS AND THE HANDLES ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2020-01317, 2. 3005168196-2020-01318, 3. 3005168196-2020-01319.

    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: 3005168196-2020-01317, 3005168196-2020-01318, 3005168196-2020-01319.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL INTO THE TIP OF THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, AFTER TWO ATTEMPTS, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN DEPRESSED THE HANDLE AND PULLED IT BACK BEFORE HEARING AN AUDIBLE CLICK; BUT THE SMART COIL DID NOT DETACH. THEN, THE PHYSICIAN MANUALLY PULLED APART THE MICROCATHETER TO PULL THE PUSHER ASSEMBLY OF THE SMART COIL TO DETACH IT; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. NEXT, THE PHYSICIAN PLACED AND DETACHED MULTIPLE SMART COILS INTO THE TARGET VESSEL USING A NEW HANDLE. WHILE ADVANCING TWO ADDITIONAL SMART COILS, THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN ITS INTRODUCER SHEATH. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE AND DETACHED BOTH SMART COILS INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, THE SAME SECOND HANDLE, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931383 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. SCH1 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR