BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 6968963 · Received October 23, 2017

    Report

    Report Number
    3005168196-2017-01853
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 15, 2017
    Report Date
    September 26, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016733
    PMA / PMN Number
    K170852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION TO PMA/510K: K170852 THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0 AND 13.0 CM FROM THE PROXIMAL END. THE STRETCH RESISTANCE WIRE (SR WIRE) WAS FRACTURED AND THE PROXIMAL CONSTRAINT SPHERE WAS INSIDE THE DDT. THE INTRODUCER SHEATH HAD COAGULATED BLOOD INSIDE AND THE EMBOLIZATION COIL WAS STUCK IN THE INTRODUCER SHEATH. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SR WIRE WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS FORCEFULLY RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. THE DISTAL TIP OF THE PODJ WAS NOT BROKEN. BASED ON THE RETURNED CONDITIONS, THE ROOT CAUSE OF THE RESISTANCE EXPERIENCED DURING ADVANCEMENT THROUGH THE LANTERN COULD NOT BE DETERMINED. THE LANTERN MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE KINKS IN THE PUSHER ASSEMBLY WERE LIKELY INCIDENTAL AND MAY HAVE OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A MASSIVE PULMONARY ARTERY BLEED USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THE INITIAL PENUMBRA COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH THE SAME LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE COIL. HOWEVER, WHILE ATTEMPTING TO WITHDRAW THE PODJ, THE PHYSICIAN EXPERIENCED RESISTANCE AND INSTEAD REMOVED THE LANTERN CONTAINING THE PODJ ALL TOGETHER. ONCE THE LANTERN WAS REMOVED FROM THE PATIENTS BODY, THE PODJ WAS PULLED OUT FROM THE LANTERN AND THE DISTAL END OF THE PODJ BROKE. THE LANTERN WAS THEN REINSERTED INTO THE PATIENTS BODY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A TOTAL OF EIGHT PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747738 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. F69547 00814548016733

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR