BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 5856995 · Received August 9, 2016

    Report

    Report Number
    9612452-2016-00029
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    February 5, 2016
    Report Date
    September 23, 2016
    Manufacturer
    B.BRAUN MEDICAL SAS - OWNER
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REOPENED AT THE RECEPTION OF THE X-RAY PICTURES. EXAMINATION OF THE X-RAY PICTURE: THE X-RAY PICTURE SHOWS : A CONTRAST MEDIA POOL AT THE LEVEL OF THE PATIENT'S CHEST. THAT THE CATHETER IS NOT RUPTURED. THAT THE CATHETER TIP IS HIGHLY POSITIONED IN THE SUPERIOR VENA CAVA AND NOT AT THE ENTRANCE OF THE HEART, AS RECOMMENDED. THE PRESENCE OF A FIBRIN SLEEVE AROUND THE CATHETER. THIS FIBRIN SLEEVE EXPLAINS THE LEAK EFFECT REPORTED BY THE USER. IN FACT DURING THE INJECTION, THE SOLUTION FLOWS BACK BETWEEN THE FIBRIN SLEEVE AND THE CATHETER AND THEN CREATES A LITTLE POOL, WHICH COULD BE CONFUSED WITH A LEAK AT THE END OF THE FIBRIN SLEEVE. CONCLUSION: THE DEVICE CONFORMS TO OUR SPECIFICATIONS. NO PERFORATIONS/HOLES HAVE BEEN DETECTED ON THE CATHETER. THE LEAK REPORTED BY THE USER IS NOT A REAL LEAK BUT RESULTS FROM THE PRESENCE OF A FIBRIN SLEEVE AROUND THE CATHETER. A HIGH POSITION OF THE CATHETER IN THE SUPERIOR VENA CAVA FAVORS THE DEVELOPMENT OF FIBRIN AROUND THE CATHETER. IT IS AN KNOWN POTENTIAL COMPLICATIONS OF CATHETER IMPLANTATION. AS MENTIONED IN THE IFU, "IT IS RECOMMENDED TO PLACE THE CATHETER TIP IN THE SUPERIOR VENA CAVA, AT THE ENTRANCE OF THE RIGHT ATRIUM TAKING INTO ACCOUNT POSSIBLE CATHETER TIP MOVEMENT." NO CORRECTIVE ACTION IS ENVISAGED.

    Additional Manufacturer Narrative · 1

    NOTE: PRODUCT REFERENCE 4430085 IS NOT CLEARED IN USA, BUT THIS REFERENCE HAS THE SAME CATHETER AS THE PRODUCT REFERENCE (B)(4) CLEARED UNDER # 510K130576. BATCH HISTORY REVIEW: THE BATCH HISTORY REVIEW WAS PERFORMED. THE BATCH HAS BEEN MANUFACTURED IN COMPLIANCE WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER SIMILAR INCIDENT HAS BEEN DECLARED THIS BATCH OF ACCESS PORTS RELEASED IN FEBRUARY 2011. INVESTIGATION RESULTS: A CELSITE T205 ACCESS PORT FROM BATCH K0211610 HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ACCESS PORT WAS NOT CLEANED BEFORE HAVING BEEN SENT TO THE MANUFACTURER: A LOT OF FLESH, TISSUE AND/OR FIBRIN REMAINS AROUND THE CONNECTION. AFTER CLEANING, IT APPEARS THAT THE ACCESS PORT IS STILL CONNECTED TO A 19.1 CM LONG CATHETER WITH THE CONNECTION RING. NO DEFECT IS VISIBLE. INJECTION TEST: AN INJECTION TEST HAS BEEN PERFORMED: NO LEAK OR ABNORMALITY DETECTED. THEN THE CATHETER HAS BEEN PINCHED AND AN INJECTION TEST UNDER A PRESSURE OF 6 BARS HAS BEEN PERFORMED: NO LEAK DETECTED. DIMENSIONAL MEASUREMENTS: THE DEVICE DIMENSIONALLY CONFORMS TO THE SPECIFICATIONS. CONCLUSION: THE ACCESS PORT DOES NOT PRESENT ANY LEAK. NO DEFECT HAS BEEN DETECTED ON THE RETURNED SAMPLE. THE INCIDENT DESCRIPTION AND THE INVESTIGATION RESULTS ALLOW TO HYPOTHESIS THAT THE LEAK DETECTED BY THE CUSTOMER RESULTS FROM THE FORMATION OF A FIBRIN SLEEVE AROUND THE CATHETER. WHEN A FIBRIN SLEEVE IS FORMED AROUND A CATHETER, THE INJECTED PRODUCT REFLUX ALONG THE CATHETER AND LEAK OUT OF THE VEIN. ONLY THE EXAMINATION OF THE X-RAY PICTURES COULD ALLOW TO CONFIRM THIS HYPOTHESIS BUT THEY WERE NOT FORWARDED TO MANUFACTURER FOR ANALYSIS. THE DEVICE RECEIVED CONFORMS TO OUR SPECIFICATION. NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    THERE WAS A LEAKAGE IN THE PORT SYSTEM PLACED IN LEFT PECTORAL. THE SYSTEM WAS INTRODUCED ON (B)(6) 2011. A CONTRAST MEDIA INVESTIGATION SHOWED A LEAKAGE AT ABOUT THE PROXIMAL THIRD OF THE PORT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507881 CELSITE ACCESS PORT SYTEM LJT B.BRAUN MEDICAL SAS - OWNER 4430085 K0211610

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention