BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 21138043 · Received January 13, 2025

    Report

    Report Number
    1282497-2025-00022
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    November 9, 2024
    Report Date
    January 13, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK DY, DIALYSIS UNKNOWN, N/A CATHETER-RELATED RIGHT ATRIAL THROMBOSIS: A CASE SERIES JUAN FRANCISCO RODRÍGUEZ ALVARADO, RAUL CRUZ PALOMERA, EDUARDO SÁNCHEZ CORTÉS, JORGE GUILLERMO ARENAS FONSECA, JOSÉ DARÍO VALENCIA GONZÁLEZ ACCEPTED: 11`.09.2024 HEART VESSELS TRANSPLANT 2024; 8: DOI: 10.24969/HVT.2024.516. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE RETROSPECTIVE STUDY, A 56-YEAR-OLD WOMAN WITH CHRONIC KIDNEY DISEASE (CKD) UNDERWENT RENAL REPLACEMENT THERAPY (RRT) WITH HEMODIALYSIS. HOWEVER, THE PATIENT'S CONDITION DETERIORATED DUE TO THROMBUS FORMATION IN THE CATHETER, RESULTING IN OBSTRUCTION OF THE TRICUSPID VALVE. CONSEQUENTLY, THE PATIENT UNDERWENT SURGICAL THROMBECTOMY, WHICH YIELDED A FAVORABLE OUTCOME. A 56-YEAR-OLD WOMAN WITH MULTIPLE CARDIOVASCULAR RISK FACTORS, INCLUDING TYPE 2 DIABETES MELLITUS, OBESITY, MENOPAUSE, DYSLIPIDEMIA, HYPERTENSION, AND CHRONIC KIDNEY DISEASE (CKD), WAS PRESENTED. HISTORY OF STAGE V CKD REQUIRING HEMODIALYSIS HISTORY OF STAGE V CKD REQUIRING HEMODIALYSIS, DEVELOPED DYSPNEA NYHA CLASS II, WITHOUT FEVER. IT WAS NOTED THAT THE CATHETER FROM THE SUPERIOR VENA CAVA (SVC) EXTENDED 3 CM BEYOND THE JUNCTION BETWEEN THE SVC AND THE RA, WITH THE LATTER BEING VISIBLE INSIDE THE RA. EMBOLISM. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452615 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R