BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM IMPLANTABLE PORT

    MDR report key: 7948646 · Received October 9, 2018

    Report

    Report Number
    2020394-2018-01880
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. JOURNAL ARTICLE REVIEW: THE JOURNAL ARTICLE WAS A RETROSPECTIVE OF 12 YEARS FROM 2003 THROUGH 2015 TO INCLUDE A TOTAL OF 527 PORT-A-CATH¿S PLACED IN ADULT PATIENTS. 262 CHEST PORTS WERE PLACED IN THE OPERATING ROOM AND 265 CHEST PORTS WERE PERFORMED IN AN OUTPATIENT CLINIC. PATIENT CHARACTERISTICS WERE SIMILAR; THERE IS NO SIGNIFICANT DIFFERENCE IN EARLY VERSUS LATE COMPLICATIONS. BARD TITANIUM IMPLANTABLE PORTS AND DISTRICATH PORTS WERE USED FOR THE STUDY. PORT-A-CATH TIP MALPOSITION WAS OBSERVED IN SEVEN CASES WHICH REQUIRED REPOSITIONING UNDER GUIDED FLUOROSCOPY. PNEUMOTHORAX OCCURRED IN THREE CASES: ONE PATIENT WAS TREATED CONSERVATIVELY, ONE PATIENT REQUIRED HOSPITALIZATION WITH A CHEST TUBE INSERTION, AND THE THIRD PATIENT HAD A CHEST TUBE INSERTION AN OUTPATIENT CLINIC. LATER COMPLICATIONS INCLUDE VENOUS THROMBOSIS IN ONE PATIENT AND TREATED WITH THE LOW MOLECULAR WEIGHT HEPARIN. CATHETER OCCLUSION OCCURRED IN FOUR PATIENTS WHICH REQUIRED PORT-A-CATH REMOVAL AND REPLACEMENT. FEO, C., GINESU, G., BELLINI, A., CHERCHI, G., SCANU, A., COSSU, M., FANCELLU, A., PORCU, A. (2017). COST AND MORBIDITY ANALYSIS OF CHEST PORT INSERTION IN ADULTS: OUTPATIENT CLINIC VERSUS OPERATING ROOM PLACEMENT (2017). ANNALS OF MEDICINE AND SURGERY, 21, 81-84. HTTP://DX/DOI.ORG/10.1016/J.AMSU.2017.07.057. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN ANNALS OF MEDICINE AND SURGERY TITLED 'COST AND MORBIDITY ANALYSIS OF CHEST PORT INSERTION IN ADULTS: OUTPATIENT CLINIC VERSUS OPERATING ROOM PLACEMENT', THAT A 12 YEAR RETROSPECTIVE FOR PORT-A-CATH PLACEMENTS IN 527 PATIENTS WAS PERFORMED. REPORTED COMPLICATIONS INCLUDED: PORT-A-CATH TIP MALPOSITION, PNEUMOTHORAX WHICH RESULTED IN CHEST TUBE INSERTION, VENOUS THROMBOSIS, AND CATHETER OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788057 TITANIUM IMPLANTABLE PORT TITANIUM IMPLANTABLE PORT LJT BARD ACCESS SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L HEPARIN