BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD8

    MDR report key: 4182199 · Received October 17, 2014

    Report

    Report Number
    3005168196-2014-00726
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULT: THE COIL AND PET LOCK WERE STILL INTACT WITH THE PUSHER ASSEMBLY. THE COIL INTRODUCER SHEATH WAS OVALIZED APPROXIMATELY 52.0 CM FROM THE DISTAL TIP. THE OUTER DIAMETER OF THE POD8 AND PUSHER ASSEMBLY WERE MEASURED AND DETERMINED TO BE WITHIN SPECIFICATION. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE POD8 DEVICE WAS INSERTED INTO A 0.027" DIREXION MICROCATHETER (A NON-PENUMBRA DEVICE) AND EXPERIENCED FRICTION WHEN PUSHING THROUGH THE MICROCATHETER. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THAT THE POD8 WAS DIMENSIONALLY WITHIN SPECIFICATION; HOWEVER, THE DEVICE INTRODUCER SHEATH WAS OVALIZED. THE OVALIZED AREA WAS APPROXIMATELY IN THE MIDDLE OF THE INTRODUCER SHEATH. THIS DAMAGE COULD HAVE CONTRIBUTED TO FRICTION WHILE ADVANCING THE COIL INTO THE MICROCATHETER. THE OVALIZATION WAS LIKELY RELATED TO OVER TIGHTENING THE ROTATING HEMOSTATIC VALVE (RHV) ON THE INTRODUCER SHEATH. THE FRICTION WHEN TRANSFERRING THE DEVICE INTO THE MICROCATHETER DURING THE DEVICE INVESTIGATION COULD NOT BE DETERMINED. ONCE THE POD8 WAS INSIDE THE MICROCATHETER, THE DEVICE WAS FULLY FUNCTIONAL. THE POD8 DEVICES ARE 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 IN THE SPLENIC ARTERY USING A POD8. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A POD8 THROUGH ANOTHER MANUFACTURER'S MICROCATHETER. THE MICROCATHETER WAS FLUSHED AND THE POD8 STILL WOULD NOT ADVANCE. THE POD8 WAS REMOVED AND ANOTHER POD8 WAS SUCCESSFULLY USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD8. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A POD8 THROUGH ANOTHER MANUFACTURER'S MICROCATHETER. THE MICROCATHETER WAS FLUSHED AND THE POD8 STILL WOULD NOT ADVANCE. THE POD8 WAS REMOVED AND ANOTHER POD8 WAS SUCCESSFULLY USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661856 POD8 HCG, KRD HCG PENUMBRA, INC. F60379

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR