BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 6173906 · Received December 14, 2016

    Report

    Report Number
    2522007-2016-00013
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DWF
    UDI-DI
    00827002264892
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), FUNCTIONAL TESTING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED VITAL PORT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EXAMINED AND FUNCTIONALLY TESTED FOR DEVICE OCCLUSION. THE CATHETER LENGTH FROM THE PORT BASE TO THE CATHETER END WAS APPROXIMATELY 43.6CM. THE PORT, THE CATHETER AND CATHETER LOCK WERE ASSEMBLED WHEN RECEIVED. THERE WAS NO CALCIFICATION OR BURNISHING ON THE CATHETER; ALL SURFACES WERE SMOOTH, NO NICKS, ABRASIONS OR PUNCTURES COULD BE SEEN WITH INCREASED MAGNIFICATION. THE SEPTUM SHOWED SIGNS OF NEEDLE MARKS. THERE WAS NO EVIDENCE THAT THE SUTURE HOLES WERE UTILIZED AS THE IFU INDICATES. BOTH THE PORT AND THE CATHETER WERE NOT OCCLUDED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS 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, EXAMINATION OF THE RETURNED DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CHAMBER AND CATHETER WERE SEPARATED INSIDE THE PATIENT'S BODY AFTER ONE DAY OF THE PROCEDURE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REPLACE THE DEVICE WITH A NEW ONE ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824988 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF COOK VASCULAR INC N/A 00827002264892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention