BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7042811 · Received November 17, 2017

    Report

    Report Number
    2522007-2017-00036
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    December 1, 2016
    Report Date
    March 20, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    PMA / PMN Number
    K081425
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K)# K081425. INVESTIGATION SUMMARY: THE REPORT EVENT WAS UNABLE TO BE CONFIRMED AS DEVICE WAS NOT RECEIVED. THE PART NUMBER/LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN AS WELL. THE QUALITY ENGINEERING AND ENGINEERING DEPARTMENTS COULD NOT PERFORM AN EVALUATION, THEREFORE, A DETERMINATION IF THE DEVICE WAS DEFECTIVE IS INCONCLUSIVE. A PHYSICAL INVESTIGATION WAS NOT PERFORMED. THIS COMPLAINT EVENT IS A KNOWN FAILURE MODE OF THIS DEVICE AND WILL BE MONITORED AND TRENDED VIA THE COMPLAINT HANDLING AND POST MARKET PROCESSES. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE 6-8 CM LINE OF THE VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT BROKE OFF, AND HAD TO BE REMOVED FROM THE PATIENT'S RIGHT HEART VENTRICLE. THE PATIENT WAS RECEIVING CHEMOTHERAPY VIA THE SUBCLAVIAN. THE PATIENT REPORTEDLY EXPERIENCED GREAT DISCOMFORT DURING THE REMOVAL. THE ISSUE OCCURRED ON (B)(6) 2016, AND THE DEVICE PORT WAS INSERTED APPROXIMATELY TWO MONTHS BEFORE THE INCIDENT OCCURRED. FOLLOWING THE REMOVAL OF THE DEVICE BY THE RADIOLOGIST, IN CASE THEY WANTED THE TIP TESTED FOR INFECTION, WHICH IS STANDARD PROCEDURE AFTER THE REMOVAL OF A CATHETER TIP. THE DEVICE WAS ULTIMATELY DISCARDED, AND IS NOT AVAILABLE FOR IDENTIFICATION OR EVALUATION. PER THE CUSTOMER, THERE IS NO DOCUMENTATION REGARDING THE IDENTITY OF THE DEVICE USED ON THE PATIENT, AND THE HOSPITAL CANNOT CONFIRM THE NAME OF THE SUPPLIER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821442 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 72 YR Required Intervention