BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

    MDR report key: 3040589 · Received April 8, 2013

    Report

    Report Number
    3005168196-2013-00114
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETER APPEARS TO BE SMASHED/PINCHED IN THE PROXIMAL PORTION OF THE SHAFT APPROXIMATELY (13.5CM) FROM THE HUB. CONCLUSION: THE COMPLAINT WAS EVALUATED AND CONFIRMED. THE PHYSICIAN'S COMPLAINT WAS THAT THE 5MAX CATHETER COLLAPSED WHEN TIGHTENING THE RHV TWICE. BASED ON THE RESULTS OF THE PRODUCT EVALUATION AND THE COMPLAINT DESCRIPTION, IT APPEARS THAT WHILE TIGHTENING THE NEURON MAX RHV ONTO THE PROXIMAL SHAFT OF THE 5MAX, THE PHYSICIAN OVER TIGHTENED THE RHV CAUSING THE LUMEN TO COMPRESS. THIS RESULTED IN THE FRICTION THE PHYSICIAN EXPERIENCED. CARE MUST BE TAKEN TO ENSURE THE RHV VALVE IS SNUG, BUT NOT OVER TIGHTENED. 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 3005168196-2013-00115.

    Description of Event or Problem · 1

    DURING TREATMENT OF A STROKE THE PHYSICIAN WAS USING A 5MAX REPERFUSION CATHETER WITH A NEURON MAX AND PACKAGED RHV. PHYSICIAN FIRST INTRODUCED A 5MAX WITHOUT ANYTHING INSIDE, SUCH AS A WIRE OR MICROCATHETER. HE THEN ATTEMPTED A COAXIAL TECHNIQUE WITH VELOCITY MICROCATHETER AND MICRO GUIDEWIRE. HOWEVER, HE ENCOUNTERED PROBLEMS WHEN TRYING TO ADVANCE THE VELOCITY MICROCATHETER THROUGH THE 5MAX. INITIALLY PHYSICIAN ASSUMED THERE WAS A PROBLEM WITH THE VELOCITY MICROCATHETER SO HE ATTEMPTED AGAIN WITH A DIFFERENT MAKE OF MICROCATHETER, BUT WAS NOT ABLE TO ADVANCE THIS ONE EITHER. IT WAS THEN APPARENT THAT THE 5MAX HAD COLLAPSED UNDER THE RHV. PHYSICIAN TRIED AGAIN WITH ANOTHER 5MAX, BUT THE SAME THING HAPPENED AGAIN. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143425 PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. PSC054L125

    Patients

    Seq Age Sex Outcome Treatment
    1