BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 14886047 · Received July 1, 2022

    Report

    Report Number
    9612452-2022-00029
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 1, 2022
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: PRODUCT REFERENCE 4433742 IS NOT CLEARED FOR SALES IN THE USA, BUT IT IS SIMILAR TO THE PRODUCT REFERENCE 5433742 CLEARED UNDER #510K130576. BATCH HISTORY REVIEW: WE HAVE CHECKED THE MANUFACTURING FILE OF THE INVOLVED BATCH WHICH COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER SIMILAR COMPLAINT WAS REPORTED TO US ON THIS BATCH OF ACCESS PORTS RELEASED IN MAY 2014. INVESTIGATION RESULTS WE DID NOT RECEIVE THE COMPLAINT SAMPLE FOR INVESTIGATION. HOWEVER, THE COLLECTED INFORMATION IS COMPLETE: CATHETER IMPLANTED VIA LEFT SUBCLAVIAN VEIN. IMPLANTED IN 2014 ON A (B)(6) MONTHS OLD CHILD. IMPLANTATION PERIOD > 8 YEARS. RUPTURE DURING ACCESS PORT WITHDRAWAL. ADHESIONS THAT DO NOT ALLOW REMOVAL BY SIMPLE TRACTION. CATHETER THAT REMAINS FIXED TO THE VESSEL AT THE POINT OF RUPTURE. X-RAY PICTURES REVIEW: ON THE X-RAY PICTURE TAKEN THE DAY OF IMPLANTATION, WE CAN SEE THE ACCESS PORT AND CATHETER IMPLANTED VIA THE LEFT SUBCLAVIAN APPROACH. THE CATHETER TIP IS CORRECTLY POSITIONED AT THE ENTRANCE OF THE RIGHT VENTRICLE. THE CATHETER FORMS AN ACUTE ANGLE JUST AFTER THE CONNECTION RING. CONCLUSION: THE INFORMATION RECEIVED ALLOW US TO THINK THAT THE CATHETER WAS ENCAPSULATED INTO THE VESSEL WALL WHEN THE ACCESS PORT REMOVAL WAS ATTEMPTED; THIS HAS LED TO THE CATHETER RUPTURE DURING ITS TRACTION. THIS INCIDENT IS A KNOWN COMPLICATION OF THE ACCESS PORT LONG TERM IMPLANTATION (8 YEARS IN THIS CASE), PARTICULARLY FOR YOUNG PATIENTS. IN ADDITION, THIS ACCESS PORT HAS REMAINED IMPLANTED IN THE PATIENT FOR TOO LONG. THE PATIENT GREW A LOT BETWEEN HIS 11 MONTHS AND HIS 8 YEARS. THIS LEADS TO DISPLACEMENT OF THE DISTAL END OF THE CATHETER HIGH IN THE VCI. THIS HIGH POSITION PREDISPOSES THE CATHETER TO FIBRIN SHEATH FORMATION AND OTHER MECHANICAL DIFFICULTIES. THE IFU INFORMS THE PHYSICIAN ABOUT THE IMPLANT DURATION AND THE CARE TO TAKE DURING REMOVAL PROCEDURE. THE CATHETER ENCAPSULATION AND/OR RUPTURE DURING REMOVAL OF LONG-TERM IMPLANTATIONS IS A KNOWN COMPLICATION OF ACCESS PORTS WITH THIN CATHETERS. THE COMPLAINT RATE IS LOW (B)(4). NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 0

    THE IMPLANTABLE PORT WAS PLACED IN THE PATIENT IN 2014. PROBLEM ENCOUNTERED: WHEN REMOVING THE IMPLANTABLE PORT: THE MATERIAL WAS CRACKED, WORN AND TORN. THE OPERATION THEREFORE REQUIRED THE INTERVENTION OF A VASCULAR SURGEON. THE INTERVENTION TIME WAS LONGER THAN EXPECTED AND THE ENTIRE INTERVENTION COULD NOT BE CARRIED OUT, THEREFORE THE PATIENT WAS RESCHEDULED. THE PATIENT WAS (B)(6) MONTHS OLD WHEN THE CELSITE WAS PLACED. THE TREATMENT WAS SOLUMEDROL. THE CELSITE IS NOT USED ANYMORE SINCE 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206020 CELSITE ACCESS PORT SYSTEM LJT B.BRAUN MEDICAL SAS 4433742 N108573T

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown Required Intervention