BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 5965102 · Received September 20, 2016

    Report

    Report Number
    3005168196-2016-01333
    Event Type
    Malfunction
    Date Received
    September 20, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 22, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016719
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A REFLUX IN THE GONADAL VEIN USING POD PACKING COILS (PODJ COIL). DURING THE PROCEDURE, THE PHYSICIAN INADVERTENTLY ADVANCED ANOTHER MANUFACTURER'S DIAGNOSTIC CATHETER PAST THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND THEN PROCEEDED TO ADVANCE A PODJ COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL. HOWEVER, THE COIL PARTIALLY FORMED AND PACKED INSIDE THE DIAGNOSTIC CATHETER. WHILE ATTEMPTING TO RETRACT THE PODJ COIL, THE PHYSICIAN MET RESISTANCE AND DECIDED TO WITHDRAW THE DIAGNOSTIC CATHETER AND THE LANTERN AS A SYSTEM. THE PODJ COIL WAS THEN REMOVED FROM THE DIAGNOSTIC CATHETER AND THE SAME DIAGNOSTIC CATHETER AND LANTERN WERE RE-INSERTED INTO THE PATIENT'S BODY TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NEW PODJ COILS AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614228 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. F70345 00814548016719

    Patients

    Seq Age Sex Outcome Treatment
    1