BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 2403948 · Received January 5, 2012

    Report

    Report Number
    2522007-2011-00018
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    November 25, 2011
    Report Date
    December 29, 2011
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DWF
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ENGINEERING REPORTED, "THE DEVICE WAS NOT RETURNED FOR AN INVESTIGATION. SEVERAL X-RAY IMAGES WERE SENT AND REVIEWED." ENGINEERING STATED, "THE IMAGES DID NOT PROVIDE SUFFICIENT INFORMATION FOR A THOROUGH INVESTIGATION." ENGINEERING STATED, "NONE. NO NON-CONFORMITIES WERE FOUND DURING THE INVESTIGATION."

    Description of Event or Problem · 1

    COOK (B)(4) REPORTED FOR THE CUSTOMER, "CATHETER DISLOCATED AND MIGRATED TO THE HEART. PORT WAS REMOVED." PER COMPLAINT FORM: "THEY HAVE IMPLANTED A PERIPHERAL PORT CATHETER DEVICE. AFTER THE PROCEDURE IT LOOKS LIKE ALL VERY WELL, BUT ON THE WARD THE PORT DOESN'T WORK. SO THEY MADE A OVERVIEW AND THE PORT CATHETER WAS DISLOCATED IN THE RIGHT HEART, SO THEY STARTED TO RETRIEVE THE CATHETER IN THE CATH LAB AND REMOVE THE PORT CHAMBER." CATHETER SECTION WAS REMOVED USING A SNARE OVER A LONG SHEATH THROUGH THE FEMORAL VEIN. ADDITIONAL PROCEDURE: PORT EXPLANT. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER DWF COOK VASCULAR INC. IP-S5116W-MPIS-NT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR