BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    MDR report key: 5200251 · Received November 4, 2015

    Report

    Report Number
    1820334-2015-00727
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 19, 2015
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) K081425. EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY AND DEVICE HISTORY RECORD WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. PER THE CUSTOMER REPORT, THE LOCKING SLEEVE DETACHED FROM THE CATHETER DURING REMOVAL OF THE DEVICE AND REMAINS IN THE PATIENT. THERE IS NO INDICATION THAT THE PATIENT WAS HARMED OR EXPERIENCED NEGATIVE HEALTH EFFECTS AS A RESULT OF THIS EVENT. THIS IS A KNOWN FAILURE MODE THAT IS DOCUMENTED IN THE DFMECA FOR THIS DEVICE. MANUFACTURING RECORDS WERE REVIEWED AND NO EVIDENCE OF NONCONFORMITY WAS FOUND. NO OTHER COMPLAINTS HAVE BEEN FILED FOR THIS PRODUCT LOT. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. IT IS UNCLEAR IF THE SILICONE SLEEVE DETACHED BECAUSE OF DAMAGED CAUSED BY A SURGICAL TOOL, IMPROPER ATTACHMENT, MECHANICAL DEFECT, OR IF THE DURATION OF THE IMPLANTATION CONTRIBUTED TO THE EVENT. WITHOUT MORE INFORMATION, A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    WHEN THE USER WAS TAKING THE PORT OUT, THE CATHETER SLEEVE DETACHED FROM THE CATHETER AND WAS LEFT IN THE PATIENT AS A FOREIGN BODY. THEY CHOSE TO LEAVE THE SLEEVE IN THE PATIENT. THE CATHETER WAS PLACED ON (B)(6) 2012. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED IN REGARDS TO THE DECISION WHETHER THE SLEEVE WILL BE REMOVED OR BE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730911 VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER LJT COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA