BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2974088 · Received February 22, 2013

    Report

    Report Number
    3005168196-2013-00069
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL IS STUCK INSIDE THE PXSLIM CATHETER. THE COIL APPEARS TO BE STUCK APPROXIMATELY (5.0CM) FROM THE DISTAL TIP OF THE CATHETER. THE COIL WAS PUSHED OUT OF THE CATHETER WITH A PRESSURIZED SYRINGE. THE COIL IS BROKEN AS EVIDENCED BY THE CONSTRAINT BALL AND THE SR-WIRE MISSING FROM THE PROXIMAL END OF THE COIL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. BASED ON THE DESCRIPTION OF THE COMPLAINT, THE PHYSICIAN BELIEVES THAT THERE WAS A PREMATURE DETACHMENT OF THE COIL DURING THE PROCEDURE. THE PUSHER ASSEMBLY DID NOT RETURN THEREFORE, WE CANNOT DETERMINE IF THE PROXIMAL PET LOCK WAS INTACT, INDICATING AN UNINTENTIONAL DETACHMENT. HOWEVER, BASED ON THE MISSING CONSTRAINT BALL AND BROKEN SR WIRE, IT APPEARS THAT DURING MANIPULATION OF THE COIL IN THE PATIENT, THE TENSILE STRENGTH OF THE COIL SR WIRE WAS EXCEEDED CAUSING THE WIRE TO BREAK AND THE COIL IN UNINTENTIONALLY DETACH. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    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.

    Description of Event or Problem · 1

    THE PHYSICIAN EXPLAINED THAT THE COIL PREMATURELY DETACHED. IT WAS THE LAST COIL PLACED IN THE ANEURYSM AND IT STAYED INSIDE THE MICROCATHETER. THE ANATOMY OF THE VESSELS AND THE ANEURYSM ARE UNKNOWN. THERE WAS NO ASSOCIATED PATIENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77822 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F25060

    Patients

    Seq Age Sex Outcome Treatment
    1