BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT

    MDR report key: 6332169 · Received February 15, 2017

    Report

    Report Number
    2522007-2017-00004
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    November 18, 2016
    Report Date
    August 8, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    UDI-DI
    00827002264496
    PMA / PMN Number
    K910005
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE CATHETER HAD FRACTURED. THE BROKEN PORTION HAD A ROUGH APPEARANCE, WITH JAGGED SURFACES ON THE EDGES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    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.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A VITAL-PORT VASCULAR ACCESS SYSTEM IMPLANTED FOR AN UNSPECIFIED INDICATION. THE SPECIFIC SITE AND ROUTE OF IMPLANTATION WAS NOT PROVIDED. THE DEVICE ALLEGEDLY BROKE AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE SIGNS, SYMPTOMS, CIRCUMSTANCES AND CONDITIONS THAT PROMPTED A RETURN OF THE PATIENT AND INDICATED A BREAK OF THE DEVICE WERE NOT PROVIDED. X-RAYS WERE TAKEN AND CONFIRMED THAT DEVICE BROKE / SEPARATED. THE PATIENT RETURNED TO THE HOSPITAL FOR EXPLANT OF THE PORT AND REMOVAL OF THE CATHETER FROM THE RIGHT ATRIUM. ONE OF THE PEDIATRIC PHYSICIANS WITH KNOWLEDGE OF THE EVENT PROVIDED ADDITIONAL DETAILS STATING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL UNDER THE PEDIATRIC CARDIOLOGY AND ADULT INTERVENTIONAL RADIOLOGY SERVICES. "THE TUBING AND THE DEVICE ITSELF WERE COMPLETELY SEPARATED AND THE TUBING HAD MIGRATED INTO THE PATIENT SO THAT THE TIP LAY IN THE RIGHT VENTRICLE. THIS POSED A RISK FOR CARDIAC ARRHYTHMIA AS WELL AS PULMONARY EMBOLUS." "THE PATIENT WAS NOT SYMPTOMATIC BUT WAS AT RISK OF A LIFE THREATENING COMPLICATION SHOULD AN ARRHYTHMIA OR EMBOLUS OCCUR. " THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CATHETER BY WAY OF INTERVENTIONAL RADIOLOGY AND A SEPARATE PROCEDURE UNDER GENERAL ANESTHESIA TO REMOVE THE VITAL-PORT. NO FURTHER EVENT OR PATIENT STATUS DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116627 VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER LJT COOK VASCULAR INC N/A 00827002264496

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R