BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMPORT LOW-PROFILE DUAL-LUMEN IMPLANTABLE PORT WITH ATTAC

    MDR report key: 3223874 · Received July 10, 2013

    Report

    Report Number
    3006260740-2013-00336
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K964066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER REMOVAL. A LOT HISTORY REVIEW (LHR) OF REUG0812 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PORT PLACED 2 YEARS AGO AND HAS QUESTIONS ABOUT LENGTH OF PORT AND CAUSING SCAR TISSUE. PT REPORTS THAT SHE HAD A DUAL BARDPORT PLACED (B)(6) 2011, FOR CHEMO THERAPY AND POST REMOVAL (B)(6) 2011. SHE HAD A PANIC ATTACK IN (B)(6) 2013 AND HER MD DECIDED TO DO AN ECHOCARDIOGRAM AND FOUND A 2X2 CAM CALCIFIED MASS IN RIGHT ATRIUM HE DIAGNOSED AS PROBABLY SCAR TISSUE FROM PREVIOUS IMPLANTED PORT CATHETER IN THE RIGHT ATRIUM. SHE HAD A TEE TEST DONE (B)(6), 2013 AND THEY FOUND HEART SCAR TISSUE. (B)(6) 2013, SHE HAD A PET SCAN. (B)(6) 2013, SHE HAD A CARDIAC MRI AND FOUND THAT SHE HAD A BLOOD CLOT IN HER HEART ALONG WITH THE SCAR TISSUE IN HER HEART. SHE REPORTS THAT SHE HAD ALSO HAD RADIATION THERAPY OVER THE EXACT AREA DUE TO HEART CANCER. SHE REPORTS THAT SHE WAS TOLD THAT SHE WILL NEED TO HAVE HEART SURGERY TO REMOVE THE MASS AND A BLOOD CLOT. SHE HAS AN APPOINTMENT WITH A SURGEON NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316051 SLIMPORT LOW-PROFILE DUAL-LUMEN IMPLANTABLE PORT WITH ATTAC LJT C. R. BARD INC. (BASD) REUG0812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention