BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 5151986 · Received October 15, 2015

    Report

    Report Number
    3005168196-2015-01048
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 16, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548010649
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PENUMBRA COIL 400 COIL (PC400 COIL) PUSHER ASSEMBLY. THE INTRODUCER SHEATH WAS DAMAGED APPROXIMATELY 44.0 CM FROM THE PROXIMAL END. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 58.0, 100.0, AND 117.0 CM FROM THE PROXIMAL END. THE COIL WAS DETACHED FROM THE PUSHER ASSEMBLY AND NOT RETURNED FOR EVALUATION. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THE PX SLIM WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE PX SLIM IS ADVANCED OR WITHDRAWN FORCEFULLY AGAINST RESISTANCE, OR IF IT IS MANIPULATED FORCEFULLY AT AN ANGLE DURING INSERTION INTO A PATIENT, DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION REVEALED THAT THE PENUMBRA COIL 400 COIL (PC400 COIL) WAS KINKED AND THE INTRODUCER SHEATH WAS DAMAGED. THIS DAMAGE, AS WELL AS THE DIFFICULTY ADVANCING THE PC400 COIL, MAY HAVE OCCURRED DUE TO USING THE PC400 COIL WITHIN THE DAMAGED PX SLIM. PX SLIM MICROCATHETERS ARE 100% VISUALLY INSPECTED AND PC400 COILS ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2015-01047. 2. 3005168196-2015-01049.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DUE TO THE TORTUOSITY OF THE PATIENT'S VESSELS, THE PHYSICIAN DECIDED TO DELIVER THE PC400 COILS FROM THE LEFT COMMON CAROTID ARTERY THROUGH A VASCULAR PROSTHESIS BYPASS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND THE COIL BECAME STUCK AND WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM BUT MET RESISTANCE AGAIN; THE COIL BECAME STUCK AND WAS REMOVED. THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684665 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F64344 00814548010649

    Patients

    Seq Age Sex Outcome Treatment
    1