BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2970674 · Received February 20, 2013

    Report

    Report Number
    3005168196-2013-00067
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL IS STUCK INSIDE OF THE ORANGE SHEATH THAT IT GETS DEPLOYED THROUGH. THE PUSHER ASSEMBLY STILL HAS THE PET LOCK IN TACT AT THE PROXIMAL END. THIS PUSHER ASSEMBLY ALSO HAS THE CONSTRAINT BALL INSIDE THE DISTAL DETACHMENT TIP (DDT) WITH (0.8 CM) OF SR-WIRE ATTACHED. THE SR WIRE IS BROKEN. THE COIL IS NOT ATTACHED TO THE PUSHER ASSEMBLY. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE DESCRIPTION STATES THAT DURING RETRIEVAL OF THE COIL, THE COIL DETACHED INSIDE THE SHEATH. AFTER INVESTIGATING THE RETURNED PRODUCT, IT APPEARS THAT DURING RETRIEVAL OF THE COIL IT BECAME STUCK INSIDE THE SHEATH AND WHEN THE PHYSICIAN CONTINUED TO PULL THE COIL BACK, THE TENSILE STRENGTH OF THE SR WIRE MATERIAL WAS EXCEEDED CAUSING THE WIRE TO BREAK AND THE COIL TO DETACH. 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

    PATIENT WAS BEING TREATED FOR TWO INTRACRANIAL ANEURYSMS. THE LESION INVOLVED IN THIS INCIDENT WAS A CAROTID TERMINUS ANEURYSM LOCATED ON THE PATIENT'S RIGHT SIDE. IT MEASURED 12MM BY 11MM BY 11MM. THE PHYSICIAN DELIVERED THREE PC400 COILS SUCCESSFULLY INTO THE ANEURYSM USING A PXSLIMSTR CATHETER WHICH WAS PLACED THROUGH A NEURON MAX 088 90CM LONG SHEATH. THE PHYSICIAN TRIED TO DELIVER A 3X10 CURVE EXTRA SOFT, BUT WAS KICKED OUT OF THE ANEURYSM. HE RESHEATHED SUCCESSFULLY. HE THEN TRIED A SECOND TIME BUT THE COIL AGAIN COULD NOT BE PLACED. HE THEN TRIED TO RESHEATH THIS COIL. HE SUCCESSFULLY GOT THE COIL OUT OF THE SLIM MICROCATHETER, BUT THE COIL DETACHED INSIDE THE COIL INTRODUCER. HE THEN PROCEEDED TO COMPLETE THE CASE WITH TWO ADDITIONAL PC400 COILS. THERE WAS NO IMPACT ON THE PATIENT RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74641 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F27776

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR