BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6197787 · Received December 22, 2016

    Report

    Report Number
    9612452-2016-00050
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    March 31, 2016
    Report Date
    December 21, 2016
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    UDI-DI
    04046963594817
    PMA / PMN Number
    K130576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE SEVERAL REQUESTS, EITHER THE INVOLVED DEVICE NOR THE X-RAY PICTURES WERE RETURNED FOR ANALYSIS. CONCLUSION: WITHOUT THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN CONCERNING THE CAUSE OF THE CATHETER RUPTURE. CATHETER RUPTURE IS A KNOWN RISK OF ACCESS PORT IMPLANTATION, INDICATED AS A POTENTIAL COMPLICATION IN THE IFU. NO CORRECTIVE ACTION IS ENVISAGED AS THIS TYPE OF INCIDENT IS RARE. B BRAUN (B)(4) HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE TO US. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION OR THE DEVICE, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    PATIENT'S FAMILY CONTACTED B. BRAUN INTERVENTIONAL SYSTEMS TO REPORT THE FRAGMENT OF A PORT CATHETER SEVERING AND MIGRATING TO RIGHT ATRIUM, WHICH WAS SUCCESSFULLY RETRIEVED. PATIENT HAD PORT DUE TO DIAGNOSIS OF CANCER. SHORTLY AFTER DISCHARGE PATIENT FELT LIKE SOMETHING MOVED IN HER CHEST AND BEGAN EXPERIENCING CHEST PAINS. PATIENT RETURNED TO IMPLANTING HOSPITAL AND WAS TOLD THAT PAINS WERE ASSOCIATED WITH PORT "SETTLING IN" AND WAS SENT HOME. CHEST PAINS PERSISTED, PATIENT WENT TO SECOND HOSPITAL WHERE THEY PERFORMED CHEST X-RAY AND DETERMINED A PIECE OF THE PORT CATHETER BROKE OFF AND WENT INTO HEART. CATHETER SEGMENT WAS RETRIEVED PERCUTANEOUSLY THROUGH JUGULAR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849060 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 5430425 K137685U 04046963594817

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R