BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 2051138 · Received April 5, 2011

    Report

    Report Number
    2522007-2011-00006
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 1, 2011
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    LJT
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS AND CONCLUSION: ENGINEERING REPORTED, "RETURNED WAS A MINI PORT BODY WITH PROPERLY ATTACHED CATHETER SEGMENT (`8 CM) AND A SEPARATE SEGMENT OF CATHETER (APPROXIMATELY 36 CM). NO SUTURE HOLES WERE USED. THE SMALLER CATHETER SEGMENT HAD A PARTIAL FRACTURE APPROXIMATELY 1 CM PROXIMAL FROM THE PRIMARY FRACTURE LOCATION. CALCIFICATION COVERED A LENGTH (APPROXIMATELY 10 CM) OF THE LARGER CATHETER SEGMENT. THE CROSS SECTION OF THE FRACTURE AREA WAS BURNISHED OVER A LARGE PORTION." ENGINEERING STATED, "BURNISHING COULD INDICATE THAT THE FRACTURE DEVELOPED OVER A PERIOD OF TIME. THE TWO SURFACES RUB AGAINST EACH OTHER AS THE FRACTURE PROPAGATES THROUGH THE CROSS SECTION OF THE CATHETER. CHARACTERISTICS OF THE FRACTURE COULD INDICATE THAT THE CATHETER WAS REPEATEDLY PULLED OR RUBBED AGAINST A RIGID BODY. IT IS POSSIBLE THAT PATIENT ANATOMY ALONG WITH REPETITIVE MOTION COULD LEAD TO THESE CIRCUMSTANCES. IT IS SUGGESTED IN THE IFU THAT THE DEVICE BE SUTURED TO FASCIA TO MINIMIZE MOVEMENT."

    Description of Event or Problem · 1

    COOK (B)(6) REPORTED FOR THE CUSTOMER. THE CATHETER WAS CUT IN THE ARM AND MIGRATED ALONG THE VEIN. THE CATHETER WAS EXPLANTED (B)(6) 2011, THE REMAINDER OF THE PORT WILL BE EXPLANTED (B)(6) 2011 REPORT AS PER COMPLAINT FORM: "THE PATIENT GOT A PERIPHERAL MINIPORT AT THE FOREARM ON THE (B)(6) 2006 IN THE RADIOLOGY DEPARTMENT OF THE UNIVERSITY HOSPITAL IN (B)(6). THE PATIENT GOT ALL THE TIME CHEMOTHERAPY AND INFUSION ABOUT THE PORT, FOR THREE WEEKS BY NORMAL CONTROL EVERYTHING WAS OK, ON THE 10TH OF MARCH THERE WAS A PROBLEM TO FLUSH THE PORT SO THEY MAKE AN X-RAY AND SEE THAT THE CATHETER WAS DISCONNECTED IN THE UPPER ARM AND THE REST OF CATHETER WAS LYING BY THE HEART, SO THEY HAD TO REMOVE THE CATHETER WITH A RETRIEVAL DEVICE AND THE PORT BODY WAS EXPLANTED ON FRIDAY THE 11TH. AFTER EXPLANTATION THE PATIENT GOT A NEW MINIPORT DEVICE." A PIECE OF THE CATHETER WAS RETRIEVED USING A SNARE DEVICE. TWO ADDITIONAL PROCEDURES: RETRIEVAL OF THE SEPARATED CATHETER PIECE. REMOVAL OF OLD PORT AND IMPLANTATION OF A NEW ONE.

    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 LJT COOK VASCULAR INC. IP-S5116W-MPIS-NT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention