BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPEFUSION CATHETER 5MAX

    MDR report key: 2984045 · Received February 28, 2013

    Report

    Report Number
    3005168196-2013-00085
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE 5MAX CATHETER IS DAMAGED. THE PROXIMAL PORTION IS BROKEN IN TWO PIECES. THIS BREAK IS APPROXIMATELY (8.8CM) DISTAL OF THE HUB IN THE PROXIMAL PORTION OF THE CATHETER. THIS CATHETER HAS STRETCHING BETWEEN THE SUPPORT COILS IN THE SHAFT. THE 5MAX CATHETER IS NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT DESCRIPTION STATES THAT THE PHYSICIAN OVER TIGHTENED THE RHV ON THE CATHETER AND THE CATHETER WAS BROKEN DURING REMOVAL FROM THE RHV. THE BREAK WAS CAUSED BY USER ERROR. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    STROKE CASE SET-UP: NEURON MAX 90CM LONG SHEATH USED AS ACCESS - 5MAX 132CM THROUGH NEURON MAX - PX400STR THROUGH 5MAX - 3D THROUGH PX400. FIRST PASS - PX400 , 3D AND 5MAX WERE BEING REMOVED FROM THE PATIENT, THE RHV ON THE NEURON MAX WAS CLAMPING DOWN ON THE 5MAX EXTREMELY TIGHTLY. WHEN THE DOCTOR PULLED THE 5MAX WITH FORCE THE 5MAX BROKE, THE COIL REINFORCEMENT 'UNRAVELED' WITHIN THE RHV, LEAVING THE DISTAL END OF THE 5MAX INSIDE THE NEURON MAX (IN THE PATIENT) AND THE PROXIMAL / MID SECTION OF THE 5MAX OUTSIDE THE PATIENT. BOTH THE PX400 & AND 3D WERE REMOVED WITHOUT BEING DAMAGED (ALTHOUGH THEY WERE THROWN AWAY AND NEW PRODUCT OPENED FOR THE SECOND PASS). THE DOCTOR DESCRIBED IT AS THE 5MAX BEING 'SHEARED' OFF. BOTH DOCTORS INVOLVED RECOGNIZED THAT THE RHV WAS TOO TIGHT AND CAUSED THIS INCIDENT. ANOTHER 5MAX WAS OPENED AND WORKED WELL DURING THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86273 PENUMBRA SYSTEM REPEFUSION CATHETER 5MAX NRY NRY PENUMBRA, INC. F31523

    Patients

    Seq Age Sex Outcome Treatment
    1