BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 6019354 · Received October 11, 2016

    Report

    Report Number
    3005168196-2016-01448
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    July 7, 2016
    Report Date
    September 12, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011363
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2016-01449.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PENUMBRA COIL 400 (PC400) PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS BENT IN MULTIPLE LOCATIONS ALONG THE LENGTH OF THE POLYMER SECTION. THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY. DURING FUNCTIONAL ANALYSIS, A DEMONSTRATION INTRODUCER SHEATH WAS LOADED ONTO THE PC400, AND THE PC400 WAS ADVANCED THROUGH A DEMONSTRATION PX SLIM WITHOUT AN ISSUE. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THAT THE PX SLIM WAS KINKED AND OVALIZED IN MULTIPLE LOCATIONS THROUGHOUT ITS LENGTH. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE PX SLIM DURING ADVANCEMENT OR POSITIONING WITHIN PATIENT ANATOMY. THE DAMAGE OBSERVED ON THE PX SLIM LIKELY CONTRIBUTED TO THE PC400 BECOMING STUCK INSIDE THE PX SLIM DURING THE PROCEDURE. FURTHER EVALUATION REVEALED THAT THE PC400 COULD BE ADVANCED THROUGH A DEMONSTRATION PX SLIM WITHOUT AN ISSUE. THE PC400 PUSHER ASSEMBLY WAS BENT IN MULTIPLE LOCATIONS. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL MANIPULATION OF THE PC400 AFTER IT BECAME STUCK IN THE PX SLIM. PENUMBRA COILS AND CATHETERS ARE 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 PROCEDURE USING PENUMBRA COIL 400''S (PC400'S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO RETRACT THE PC400 DUE TO INCORRECT SIZING; HOWEVER, UPON RETRACTION, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM TO REMOVE THE STUCK PC400 AND NOTICED THAT THE TIP OF THE PX SLIM HAD AN ACCORDION-LIKE COMPRESSION DAMAGE. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND ADDITIONAL PC400S. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667928 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F61758 00814548011363

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR