BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 9527274 · Received December 27, 2019

    Report

    Report Number
    3005168196-2019-02416
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 28, 2019
    Report Date
    December 4, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015699
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2019-02416 1. SECTION G. BOX 3. REPORT SOURCE RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF ITS PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 109.0 AND 137.0 CM FROM ITS PROXIMAL END. THE EMBOLIZATION COIL WAS INTACT WITH ITS PUSHER ASSEMBLY. THE PUSHER ASSEMBLY MID-JOINT WAS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK. CONCLUSIONS: EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PUSHER ASSEMBLY MID-JOINT WAS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK AND THE PUSHER ASSEMBLY WAS KINKED. IF THE PUSHER ASSEMBLY MID-JOINT IS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK, RESISTANCE MAY BE EXPERIENCED DURING ADVANCEMENT AND DAMAGE SUCH AS A KINK MAY OCCUR. DURING THE FUNCTIONAL TEST, THE SMART COIL WAS RE-SHEATH CORRECTLY FROM ITS RETURNED POSITION. HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE INTRODUCER SHEATH WAS ADVANCED OVER THE KINKS IN THE PUSHER ASSEMBLY, AND THE INTRODUCER SHEATH COULD NOT BE ADVANCED ANY FURTHER. PENUMBRA COILS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETER AND, NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL. WHILE ADVANCING A SMART COIL, IT BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THE SMART COIL WAS THEN PUSHED AGAINST RESISTANCE AND ITS END BECAME BENT; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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
    1320114 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0202 F78350 00814548015699

    Patients

    Seq Age Sex Outcome Treatment
    1