BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS

    MDR report key: 7261807 · Received February 9, 2018

    Report

    Report Number
    3005168196-2018-00316
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012667
    PMA / PMN Number
    K160449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE 5MAX DDC WAS FRACTURED APPROXIMATELY 5.0 CM FROM THE HUB. THE 5MAX DDC WAS KINKED APPROXIMATELY 2.0, 25.0, AND 59.0 CM FROM THE HUB. THE 5MAX DDC WAS OVALIZED APPROXIMATELY 7.0, 114.0, AND 116.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED 5MAX DDC REVEALED A FRACTURE ON ITS PROXIMAL END. THIS DAMAGE IS LIKELY A RESULT OF FORCEFULLY ADVANCING THE DEVICE AGAINST RESISTANCE AT EXTREME ANGLES. FURTHER EVALUATION REVEALED KINKS AND OVALIZATIONS ALONG THE LENGTH OF THE RETURNED CATHETER. THESE DAMAGES WERE LIKELY INCIDENTAL AND MAY HAVE OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. THE NEURON MAX REFERRED TO IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA COILS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS (5MAX DCC'S). DURING THE PROCEDURE, WHILE IN USE WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A 5MAX DCC INTO THE PATIENT; HOWEVER, THE 5MAX DDC SPLIT AND BROKE IN HALF APPROXIMATELY AN INCH FROM THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 5MAX DDC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105140 PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS NRY NRY PENUMBRA, INC. F64505 00814548012667

    Patients

    Seq Age Sex Outcome Treatment
    1