BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 21787099 · Received April 7, 2025

    Report

    Report Number
    1282497-2025-00217
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    April 4, 2024
    Report Date
    April 7, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK DY, DIALYSIS UNKNOWN (LOT#: UNKNOWN) WIRAPORN KANCHANASUTTIRAK, VITIT LEKHAVAT, AND PONG KANCHANASUTTIRAK; LONG-TERM TUNNELED HEMODIALYSIS CATHETERS: ACHIEVING EFFICIENCY THROUGH TIP POSITION OPTIMIZATION; ANN VASC SURG 2024; 105: 158¿164, HTTPS://DOI.ORG/10.1016/J.AVSG.2024.01.018, HEMODIALYSIS PLACEMENT INSIGHTS ANNALS OF VASCULAR SURGERY VOLUME 105, AUGUST 2024. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTED, ¿A RETROSPECTIVELY REVIEWED ELECTRONIC MEDICAL RECORDS FOR 299 PATIENTS WITH CHRONIC KIDNEY DISEASE TREATED BETWEEN JANUARY 2017 AND DECEMBER 2020. THE STUDY INCLUDED PATIENTS WHO UNDERWENT TUNNELED HEMODIALYSIS CATHETER PLACEMENT IN THE RIGHT OR LEFT INTERNAL JUGULAR. EXCLUSION CRITERIA WAS USED, OMITTING 10 FEMORAL VEIN CATHETER PLACEMENTS AND 88 CASES WITHOUT POSTOPERATIVE CHEST X-RAY FILMS. ANALYSIS WAS RESTRICTED TO THE PLACEMENT OF THE PALINDROME (COVIDIEN, MANSFIELD, MA) CHRONIC HEMODIALYSIS CATHETERS, EXCLUDING 24 HEMOFLOW (MEDICAL COMPONENTS, HARLEYSVILLE, PA). THE STUDY INCLUDED 162 PATIENTS OF THAI ETHNICITY WITH 177 CATHETERS. CATHETER DYSFUNCTION WAS DEFINED AS INSUFFICIENT FLOW DURING DIALYSIS, INABILITY TO FREELY ASPIRATE BLOOD, OR FAILURE TO ACHIEVE AN EXTRACORPOREAL BLOOD FLOW OF 300 ML/MIN. PRIMARY APPROACH FOR TREATING CATHETER DYSFUNCTION WAS CATHETER EXCHANGE OVER THE GUIDEWIRE. CRBSI DIAGNOSIS REQUIRED THE PRESENCE OF THE SAME INFECTIOUS ORGANISM IN BLOOD CULTURES OBTAINED FROM BOTH THE PERIPHERAL VEINS AND THE CATHETER TIP. MOST THC PLACEMENTS INVOLVED INSERTION INTO THE RIGHT INTERNAL JUGULAR VEIN, WITH THE CATHE TER TIP PREDOMINANTLY POSITIONED IN THE RA (53%). THE OVERALL MEDIAN INDWELLING TIME FOR THCS WAS 1294 DAYS, WITH CATHETER DYSFUNCTION, CRBSI, AND OVERALL COMPLICATION INCIDENCE RATES OF 0.41, 0.19, AND 0.60 EPISODES PER 1000 CATHETER DAYS OBSERVED, RESPECTIVELY. THERE WERE 28 INSTANCES OF CATHETER DISLOCATION DURING THE FOLLOW-UP PERIOD. NOTABLY, 14 OF THESE DISLOCATIONS WERE IDENTIFIED THROUGH CHEST X-RAYS TAKEN IN VARIOUS POSITIONS (SUPINE OR UPRIGHT). THE DISLOCATION LOCATIONS WERE DISTRIBUTED AS FOLLOWS: 14% IN SVC, 54% IN CAJ, AND 32% IN RA. AMONG THE OBSERVED THC COMPLICATIONS, 56 EVENTS WERE RECORDED, WITH CATHETER DYSFUNCTION (38 CASES; 21%) FOUND TO BE MORE PREVALENT THAN CRBSI (18 CASES; 10%). THC TIP POSITION EMERGED AS THE SOLE VARIABLE SIGNIFICANTLY ASSOCIATED WITH THC COMPLICATIONS. CATHETER DYSFUNCTION, WHICH NECESSITATES THC REMOVAL OR REPLACEMENT IN 38%-57% OF CASES, AND CRBSI, REPORTED IN 16%-32% OF CASES. CATHETER MIGRATION MAY OCCUR WHEN CHANGING FROM A SUPINE TO AN UPRIGHT POSITION, CAUSING THE CATHETER TO RETRACT TOWARD THE PERIPHERY. IT WAS OBSERVED THAT THC TIPS PLACED IN THE SVC, PARTICULARLY WHEN INSERTED FROM THE LEFT INTERNAL JUGULAR VEIN, EXHIBITED HIGHER RATES OF COMPLICATIONS AS COMPARED WITH THOSE POSITIONED IN THE PCAJ OR RA. CONSEQUENTLY, THE CATHETER¿S TIP MAY BE ABUT THE LATERAL WALL OF THE SVC, POTENTIALLY CONTRIBUTING TO A HIGHER INCIDENCE OF THROMBOSIS IN LEFT-SIDE CATHETERS PLACED OVER THE SVC, WITH A REPORTED RATE OF 28.6%, COMPARED WITH RA-PLACED CATHETERS (0% RATE).¿ LONG-TERM TUNNELED HEMODIALYSIS CATHETERS: ACHIEVING EFFICIENCY THROUGH TIP POSITION OPTIMIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444093 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11