BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2923397 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00030
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 13, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHER HAS VISUAL DAMAGE. THE HYPO TUBE SHAFT OF THE PUSHER ASSEMBLY IS KINKED. THE DISTAL DETACHMENT TIP (DDT) IS MISSING FROM THE PROXIMAL END OF THE PUSHER. CONCLUSION: THE DEVICE WAS EVALUATED AND THE COMPLAINT WAS CONFIRMED. THE PHYSICIAN STATED THAT THERE MAY HAVE BEEN AN UNINTENTIONAL DETACHMENT. THE CAUSE OF THE DETACHMENT IS THE BROKEN DISTAL SEGMENT OF THE PUSHER WHICH HAS HAD THE METAL DDT PULLED OFF OF THE POLYMER SECTION OF THE PUSHER ASSEMBLY. THIS WAS LIKELY CAUSED BY APPLYING TENSILE FORCE BEYOND THE SPECIFICATION OF THE MATERIAL TO THE DDT/PUSHER ASSEMBLY POLYMER BOND WHILE DRAWING THE COIL BACK INTO THE CATHETER. IN ADDITION, THE TIP OF THE PUSHER ASSEMBLY MAY HAVE BECOME CAUGHT ON THE STENT USED DURING THE CASE WHICH MAY HAVE CAUSED THE RESISTANCE NOTED BY THE PHYSICIAN. THE PUSHER ASSEMBLY HAD MULTIPLE KINKS IN THE HYPO TUBE WHICH ALSO INDICATES RESISTANCE DURING MANIPULATION OF THE COIL IN THE PATIENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    IN AX-TREATMENT OF DISTAL ICA, 16 COILS OF 18MM X 22MM WERE USED. WHEN LAST COIL WAS BEING REPOSITIONED IT WAS STRETCHED AND DETACHED PREMATURELY. A STENT WAS USED TO PUSH THE COIL INTO THE ANEURYSM.

    Description of Event or Problem · 1

    THE LAST VOLUME COIL (J-COIL) OF A SUCCESSFUL THE AX-TREATMENT WAS STRETCHED AND MAYBE DETACHED PREMATURELY. NO CLINICAL SYMPTOMS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29226 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F22128

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention