BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2840070 · Received June 28, 2012

    Report

    Report Number
    3005168196-2012-00213
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 30, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE PX400 WAS BROKEN AND THE PROXIMAL END WAS SEPARATE FROM THE OTHER DEVICES. THE REST OF THE DEVICES WERE RETURNED INSIDE EACH OTHER (THE SEPARATOR 3D INSIDE THE DISTAL SECTION OF PX400 MICROCATHETER AND BOTH INSIDE THE REPERFUSIONS CATHETER 054). RESULTS: THE PX400 MICROCATHETER IS BROKEN AND STRETCHED AT THE TIP. THE MEASURED LENGTH FROM THE HUB-SHAFT JOINT TO THE BROKEN DISTAL END IS 143 CM WHICH INCLUDES SOME STRETCHING. THE DISTAL SECTION IS SEVERELY STRETCHED AND MEASURES 24 CM. THIS IS APPROX 16 CM LONGER THAN THE NOMINAL DEVICE LENGTH. THE ADDITIONAL LENGTH IS DUE TO SEVERE STRETCHING OF THE POLYMER. THE DISTAL END OF THE CATHETER SHOWS NO DAMAGE. THERE IS A MINOR KINK 5.2 CM FROM THE TIP OF THE REPERFUSION CATHETER 054, A CRUMPLED SECTION BETWEEN 9.8 AND 1.2 CM FROM THE TIP AND ANOTHER MINOR OVALIZATION AT 12.5 CM FROM THE DISTAL TIP. THE TIP OF THE CATHETER SHOWS NO DAMAGE. CONCLUSION: THE DAMAGE NOTED IN THE COMPLAINT WAS CONFIRMED. THERE APPEARS TO HAVE BEEN A CASCADE OF FAILURES, THE FIRST BEING THE COMPRESSION OF THE 054 CATHETER IN THE VASCULATURE AT THE SIPHON AS DESCRIBED IN THE COMPLAINT. THIS IN TURN TRAPPED THE PX400 INSIDE IT. AT THIS POINT, THE PX400 WAS STRETCHED DURING AN ATTEMPT TO PULL IT OUT OF THE PT AND THE CATHETER EVENTUALLY BROKE. IT IS UNCLEAR WHEN OR WHERE (IN THE COURSE OF THE PROCEDURE) THE SEPARATOR 3D LEG BROKE. THE NATURE AND LOCATION OF THE BREAK MEANS THAT IF IT HAD BEEN PULLED BACK INTO EITHER THE PX400 TIP OR THE PSC054 TIP, THE BROKEN LEG WOULD HAVE CAUGHT THE TIP OF THE CATHETER AND LEFT DAMAGE. NEITHER TIP IS DAMAGED. THEREFORE, IT IS POSSIBLE THAT THE SEPARATOR 3D WAS NOT BROKEN UNTIL AFTER IT WAS REMOVED FROM THE PT AND THE CLOT WAS CLEANED OFF THE DEVICE. THE MANUFACTURING RECORDS FOR THIS DEVICE HAVE BEEN REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    AN OLDER MALE PT WAS UNDERGOING STROKE TREATMENT WITH A CLOT IN THE DISTAL M1. THE PT HAD STRONG ARTERIOSCLEROSIS, AND ELONGATED AORTA, AN ELONGATED RIGHT ICA WHICH CREATED DIFFICULT ACCESS. A 7F ARROW FLEXT WAS USED TO ACCESS WITH A COAXIAL PENUMBRA SYSTEM REPERFUSIONS CATHETER 054 OVER AN 032. THE PX400 MICROCATHETER WAS THEN ADVANCED INTO THE M2 SEGMENT OF THE MCA AND THE SEPARATOR 3D WAS RELEASED. AN ANCHOR TECHNIQUE WAS USED BY BRINGING THE REPERFUSION CATHETER 054 INTO THE ANATOMY BUT IT COULD NOT BE ADVANCED HIGHER THAN THE SIPHON. THE REPERFUSION CATHETER 054 WAS DESCRIBED AS BEING IN A KIND OF "COMPRESSION." THE PHYSICIAN THEN BEGAN ASPIRATION. THE PX400 MICROCATHETER AND PSS3D WERE RETRIEVED INTO THE REPERFUSION CATHETER 054, HOWEVER, THE DISTAL END OF THE PX400 STUCK IN THE REPERFUSION CATHETER 054 IN ADDITION TO THE PSS3D AND IT WAS OBSERVED THAT THE PSS3D WAS "CUT." THE ENTIRE SYSTEM WAS RETRIEVED, THE CLOT WAS BROUGHT OUT SAFELY, AND THE PT WAS IN GOOD CONDITION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY, PRODUCT CODE: NRY NRY PENUMBRA, INC. F24601

    Patients

    Seq Age Sex Outcome Treatment
    1