BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL

    MDR report key: 20275862 · Received September 22, 2024

    Report

    Report Number
    3006260740-2024-05391
    Event Type
    Death
    Date Received
    September 22, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 15, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE POWERPORT IMPLANTABLE PORT PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE POWERPORT IMPLANTABLE PORT PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, IMAGES AND VIDEO WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 12/2022). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE POWERPORT IMPLANTABLE PORT PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE POWERPORT IMPLANTABLE PORT PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, 5 MEDICAL IMAGES WERE REVIEWED. IMAGE REVIEW SHOWED THE ENTIRE CATHETER WITHIN THE RIGHT ATRIUM, IN ONE CASE, AND A SEGMENT OF THE CATHETER IN THE INFERIOR VENA CAVA IN ANOTHER. INFILTRATE DEVELOPING IN THE LEFT LUNG AND BILATERAL PNEUMOTHORACES WERE ALSO OBSERVED. BASED ON THE IMAGE REVIEW, THE REPORTED MIGRATION CAN BE CONFIRMED, AS WELL AS IDENTIFIED DISCONNECTION. PNEUMOTHORAX IS ALSO CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE DISCONNECTION AND MIGRATION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. PATIENT DEATH AND PNEUMOTHORAX/RELATED EVENTS CANNOT BE VERIFIED TO BE RELATED TO THE PORT DEVICE. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: B5, G3, H6 (DEVICE, METHOD). H11: H6 (RESULT, CONCLUSION). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST PORT PLACEMENT IN THE RIGHT SUBCLAVIAN VEIN WITH POSITION IN THE ATRIO-CAVAL JUNCTION, THE CATHETER ALLEGEDLY MIGRATED TO THE RIGHT CARDIAC CAVITIES WITH LARGE LEFT PLEURAL EFFUSION. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED ASPIRATIVE PNEUMONIA IN THE LEFT LUNG ACCOMPANIED BY PLEURAL EFFUSION OF THE ENTIRE HEMITHORAX. REPORTEDLY, REMOVAL OF THE PORT AND FOREIGN BODY LOCATED IN THE RIGHT ATRIUM WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT DYSPNEA DID NOT IMPROVE. THE PATIENT REPORTEDLY EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST PORT PLACEMENT IN THE RIGHT SUBCLAVIAN VEIN WITH POSITION IN THE ATRIO-CAVAL JUNCTION, THE CATHETER ALLEGEDLY DISCONNECTED AND MIGRATED TO THE RIGHT CARDIAC CAVITIES WITH LARGE LEFT PLEURAL EFFUSION. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED ASPIRATIVE PNEUMONIA IN THE LEFT LUNG ACCOMPANIED BY PLEURAL EFFUSION OF THE ENTIRE HEMITHORAX. REPORTEDLY, REMOVAL OF THE PORT AND FOREIGN BODY LOCATED IN THE RIGHT ATRIUM WAS PERFORMED WITHOUT COMPLICATIONS. PATIENT DYSPNEA DID NOT IMPROVE. THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482777 POWERPORT ISP MRI 8CF INT. W/SP, ATT, SL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 REFX2979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death