BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 3841547 · Received May 30, 2014

    Report

    Report Number
    3005168196-2014-00352
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE 5MAXACE CATHETER WAS FRACTURED UNDERNEATH THE HYPO-TUBE APPROXIMATELY 1.0 CM FROM THE HUB. THE DISTAL TIP OF THE CATHETER IS OVALIZED. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT A 3MAX CATHETER WOULD NOT ADVANCE THROUGH THE 5MAXACE CATHETER. EVALUATION OF THE RETURNED DEVICE REVEALED A FRACTURE UNDERNEATH THE HYPO-TUBE APPROXIMATELY 1.0 CM FROM THE HUB IN ADDITION TO AN OVALIZATION OF THE DISTAL TIP. THE DAMAGE IN THE STRAIN RELIEF SECTION IS USUALLY ASSOCIATED WITH IMPROPER HANDLING OF THE DEVICE WHEN ATTEMPTING TO REMOVE IT FROM THE PACKAGING HOOP. IF THE PROXIMAL END OF THE CATHETER IS TORQUED OR BENT AT AN ANGLE DURING REMOVAL, THE CATHETER SHAFT MAY STRETCH AND FRACTURE IN THESE AREAS. THE OVALIZATION OF THE DISTAL TIP MAY HAVE PREVENTED A 3MAX CATHETER FROM ADVANCING PAST THE DISTAL TIP OF THE 5MAXACE CATHETER. THIS DAMAGE WAS LIKELY CAUSED DURING PREPARATION FOR USE. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PACKAGING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER. BEFORE THE PROCEDURE, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER COULD NOT BE ADVANCED THROUGH A 5MAX ACE REPERFUSION CATHETER. THE PHYSICIAN USED A DIFFERENT 5MAX ACE REPERFUSION CATHETER AND PROCEEDED WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318617 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F39632

    Patients

    Seq Age Sex Outcome Treatment
    1