BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 3812791 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00301
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAXACE CATHETER WAS FRACTURED APPROXIMATELY 1.0 CM FROM THE HUB UNDERNEATH THE HYPO-TUBE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THE 5MAXACE CATHETER WAS BEING FLUSHED PRIOR TO THE INSERTION INTO A NEURON MAX AND A LEAK WAS DISCOVERED COMING FROM A CRACK APPROXIMATELY 1.0 CM FROM THE HUB. THE COMPLAINT ALSO STATES THAT A 5MAX CATHETER WAS OPENED AND INSERTED INTO THE PATIENT. WHEN THE 5MAX CATHETER WAS WITHDRAWN THE CATHETER WAS STRETCHED. EVALUATION OF THE RETURNED DEVICES CONFIRMED A FRACTURE IN THE PROXIMAL SHAFT OF THE 5MAXACE CATHETER 1.0 CM FROM THE HUB UNDER THE HYPO-TUBE. IN ADDITION, THE REPORTED STRETCHING OF THE 5MAX CATHETER WAS CONFIRMED. IT APPEARS THAT THE 5MAXACE CATHETER WAS DAMAGED DURING REMOVAL FROM THE PACKAGING OR DURING PREPARATION FOR USE. THE DISTAL PORTION OF THE 5MAX CATHETER WAS LIKELY STRETCHED WHEN THE CATHETER WAS PULLED BACK AGAINST RESISTANCE WHICH MAY HAVE BEEN CAUSED BY TORTUOSITY IN THE VESSEL. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00316.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER AND A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER. DURING PREPARATION OF THE DEVICE, THE PHYSICIAN NOTICED THAT THE FLUSH WAS LEAKING OUT OF A CRACK IN THE 5MAX ACE CATHETER APPROXIMATELY 1 CM DISTAL TO THE HUB. THE PHYSICIAN USED A 5MAX CATHETER AND INSERTED INTO THE PATIENT'S MIDDLE CEREBRAL ARTERY (MCA) OVER A STRYKER 18L MICROCATHETER OVER A SYNCRO 014 WIRE. WHEN THE PHYSICIAN WITHDREW THE 5MAX CATHETER, IT STRETCHED AND ACCORDING TO THE PHYSICIAN, THE CATHETER APPEARED TO LOOK LIKE "PULLED TAFFY." THERE WAS NO PATIENT ADVERSE EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291115 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F40473

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR