BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 8593257 · Received May 8, 2019

    Report

    Report Number
    9612452-2019-00071
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 8, 2019
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    UDI-DI
    04038653917310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE 4430395 IS NOT CLEARED FOR SALES IN THE USA, BUT ITS CATHETER IS SIMILAR TO THE PRODUCT REFERENCE 5430395 CLEARED UNDER #510K130576. 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 SOLD SINCE OCTOBER 2017. INVESTIGATION: THE INVOLVED DEVICE IS NOT AVAILABLE FOR EVALUATION. CONCLUSION: WITHOUT THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN CONCERNING THE EXACT ROOT CAUSE OF THE CATHETER RUPTURE. HOWEVER THANKS TO THE INFORMATION RECEIVED FROM THE USER FACILITY, WE KNOW THAT THE CATHETER WAS IMPLANTED VIA THE LEFT SUBCLAVIAN VEIN AND THAT THE CATHETER RUPTURE OCCURED AT ABOUT 10 CM FROM THE DISTAL EXTREMITY OF THE CATHETER. THESE ELEMENTS SEEM TO SHOW THAT THE CATHETER RUPTURE IS DUE TO THE PINCH-OFF SYNDROME. ONLY THE EXAMINATION OF THE X-RAY PICTURES OF THE IMPLANTATION PROCEDURE COULD ALLOW US TO CONFIRM THIS HYPOTHESIS. IFU ALERTS THE USER ABOUT THIS KNOW COMPLICATION OF THE ACCESS PORT IMPLANTATION. 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

    DURING THE ACCESS PORT REMOVAL, IT WAS DETECTED THAT THE CATHETER WAS RUPTURED. THE DISTAL PART OF THE CATHETER (ABOUT 10 CM) REMAINED IN THE VASCULAR SYSTEM. THE PATIENT WAS TRANSFERRED FOR AN EXPLANTATION OF THE DISTAL PART OF THE CATHETER BY INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385023 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 4430395 36924575 04038653917310

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention