BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 4213413 · Received October 23, 2014

    Report

    Report Number
    9612452-2014-00023
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 17, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: BATCH HISTORY FILE WAS REVIEWED: IT COMPLIES WITH OUR SPECIFICATIONS AND NO ABNORMALITY WERE DETECTED DURING THE MANUFACTURING OF THIS SHEATH BATCH. THE ASSEMBLY RESISTANCE IS TESTED DURING INPROCESS AND FINAL INSPECTION. NO OTHER COMPLAINT WAS REPORTED TO US ON THIS BATCH OF (B)(4) SHEATHS SOLD SINCE (B)(4) 2014. INVESTIGATION RESULTS: WE HAVE RECEIVED THE INVOLVED SHEATH WITHOUT ITS DISTAL TIP. THE TWO PARTS OF THE SHEATH (TUBE AND TIP) ARE ASSEMBLED BY WELDING. THE RUPTURE FACIES OF THE SHEATH SHOWS THAT THE WELDING WAS CORRECTLY PERFORMED BECAUSE SOME MATERIAL FROM THE TIP IS STILL ATTACHED TO THE REST OF THE SHEATH. THE MANUFACTURING PROCESS IS VALIDATED FOR A DETACHMENT FORCE OF THE DISTAL TIP SUPERIOR TO 45 N. NO OTHER OBSERVATIONS, ALLOWING US TO UNDERSTAND THE INCIDENT, WAS MADE. NO INFORMATION ABOUT THE IMPLANTATION PROCEDURE WAS OBTAINED. CONCLUSION: THE RETURNED SHEATH DOES NOT ALLOW US TO FIND THE ROOT CAUSE OF THIS INCIDENT. NO FAILURE WAS DETECTED DURING THE ASSEMBLY OF THE SHEATH. THIS INCIDENT IS AN ISOLATED CASE. USE ERROR IS SUSPECTED. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTING THAT THE PRODUCT REFERENCE (B)(4) IS NOT APPROVED BY THE FDA, BUT THE INTRODUCER SHEATH IS THE SAME AS THE SHEATH USED FOR THE VENATECH LP KIT (5010024) CLEARED UNDER CODE # K010485.

    Description of Event or Problem · 1

    ON (B)(6) 2014: DURING THE IMPLANTATION PROCEDURE OF A VENATECH LP VENA CAVA FILTER BY FEMORAL APPROACH, THE DISTAL XRO TIP OF THE SHEATH DETACHED DURING FILTER DEPLOYMENT. POST-IMPLANTATION X-RAYS SHOW THAT THE SHEATH TIP IS CAUGHT IN ONE OF THE FILTER LEGS. NO FURTHER INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675375 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA N161228S

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other