BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 8364455 · Received February 22, 2019

    Report

    Report Number
    3005168196-2019-00350
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 25, 2019
    Report Date
    January 25, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017624
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE CATD WAS KINKED APPROXIMATELY 13.0 CM FROM THE HUB. THE CATD WAS OVALIZED APPROXIMATELY 50.5 CM FROM THE HUB. DURING FUNCTIONAL TESTING, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE A 0.088 STAINLESS STEEL MANDREL PAST THE PROXIMAL KINK IN THE CATHETER SHAFT, AND THE MANDREL COULD NOT BE ADVANCED ANY FURTHER. CONCLUSIONS: EVALUATION OF THE RETURNED CATD REVEALED THAT THE CATHETER WAS OVALIZED. THIS OVALIZATION WAS LIKELY THE ¿COMPRESSION¿ MENTIONED IN THE REPORTED COMPLAINT. IF THE DEVICE SLIPS BETWEEN THE TOP AND BOTTOM PACKAGING TRAY AND SUBSEQUENTLY, PRESSURE IS APPLIED TO THE TOP PORTION OF THE TRAY UPON REMOVAL OF THE DEVICE FROM ITS PACKAGING, DAMAGE SUCH AS OVALIZATION MAY OCCUR. FURTHER EVALUATION OF THE RETURNED CATD REVEALED A KINK. THIS KINK WAS LIKELY INCIDENTAL TO THE REPORTED ISSUE AND LIKELY OCCURRED FROM PACKAGING OF THE DEVICE FOR RETURN TO PENUMBRA. PENUMBRA CATHETERS ARE VISUALLY 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. ADDITIONAL 510(K) #S THAT ALSO APPLY TO THIS COMPLAINT: K142870; K161523.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS COMPRESSED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155759 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. F74774 00814548017624

    Patients

    Seq Age Sex Outcome Treatment
    1