BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD4

    MDR report key: 4153377 · Received October 8, 2014

    Report

    Report Number
    3005168196-2014-00701
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE POD4 PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END. THE COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PET-LOCK WAS INTACT AT THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE COIL AND PUSHER OUTER DIAMETER WERE MEASURED AND DETERMINED TO BE WITHIN SPECIFICATION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE POD4 CONTINUED TO KICK THE RENEGADE HI-FLO MICROCATHETER (A NON-PENUMBRA DEVICE) OUT OF THE VESSEL. EVALUATION OF THE RETURNED PRODUCT REVEALED NO PRODUCT DEFECTS. THE PUSHER ASSEMBLY WAS KINKED IN THE PROXIMAL REGION HOWEVER, IT APPEARS THAT THIS OCCURRED AFTER THE PROCEDURE AS IT WAS NOT DESCRIBE IN THE COMPLAINT. THE NON-PENUMBRA MICROCATHETER WAS NOT RETURNED FOR EVALUATION THEREFORE, ITS RELATIONSHIP TO THE ISSUE COULD NOT BE DETERMINED. THE DIMENSIONS OF THE POD4 COIL AND PUSHER ASSEMBLY WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. IF THE MICROCATHETER IN USE WAS A COMPATIBLE SIZE WITH THE COIL THERE SHOULD HAVE BEEN NO ISSUE WITH COMPATIBILITY. THEREFORE, IT WAS DETERMINED THAT THIS ISSUE WAS RELATED TO PATIENT ANATOMY AND MICROCATHETER POSITIONING AND WAS NOT RELATED TO ANY ISSUE WITH THE POD4 DEVICE. THE POD4 DEVICE IS 100% FUNCTIONAL TESTED DURING IN-PROCESS INSPECTION. 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 A POD4 AND ANOTHER MANUFACTURER'S MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A POD4 IN A MICROCATHETER; HOWEVER, THE MICROCATHETER KICKED BACK EACH TIME THE PHYSICIAN ADVANCED THE POD4 INTO THE TARGET VESSEL. THE PHYSICIAN REMOVED THE POD4 AND CONTINUED THE PROCEDURE USING RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630731 POD4 HCG, KRD HCG PENUMBRA, INC. F43680

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR