BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 2041156 · Received March 29, 2011

    Report

    Report Number
    2522007-2011-00005
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 28, 2011
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DWF
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING REPORTED, "AN INVENTORY OF THE RETURNED COMPONENTS INCLUDES A MINI PORT BODY, CATHETER LOCK AND TWO SEGMENTS OF CATHETER (APPROX 45 AND 2.5CM). VISUAL INSPECTION OF THE CATHETER FRACTURED REVEALED THAT THE FRACTURE SURFACE WAS BURNISHED OVER A PORTION OF THE CROSS SECTION." ENGINEERING STATED, "PARTIAL 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 PT ANATOMY ALONG WITH REPETITIVE MOTION COULD LEAD TO THESE CIRCUMSTANCES." CORRECTIVE ACTION: NONE. THERE WERE NO NONCONFORMITIES FOUND DURING THE INVESTIGATION OF THIS EVENT. # (B)(4), (B)(4).

    Description of Event or Problem · 1

    CIRL REPORTED FOR CUSTOMER CATHETER FRACTURED AT THE VENOUS SITE. THE DISTAL END OF THE CATHETER MIGRATED TOWARD PULMONARY ARTERY. DISTAL END OF THE CATHETER MIGRATED AND HAS YET TO BE REMOVED. REMOVAL HAS NOT BEEN POSSIBLE SO FAR BECAUSE OF BLOOD DILUTION. THE CATHETER WILL BE RETRIEVED IN AN ADDITIONAL PROCEDURE. NO ADVERSE EFFECTS ON THE PT 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 N80092

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention