Concomitant product: dialysis unknow (lot#: unknown); dialysis unknow (lot#: unknown) title: tunneled femoral vein catheterization for long-term hemodialysis ¿ experience from a tertiary care center source: indian journal of nephrology; volume 32; issue 4.Date of publication: 20-05-2022 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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According to the literature, a retrospective study between january 2020 and april 2021 evaluated the efficacy, catheter life, and long-term complications of tunneled hemodialysis catheters placed in the common femoral vein due to optimal vascular access exhaustion.Twenty-one patients were included in the study where either a palindrome or competitor hemodialysis catheter was placed.Right sided femoral catheter insertion was performed in 18 patients (85.7%) and 3 patients underwent left-sided insertion.All patients received intravenous vancomycin (1 g) on the day of procedure and the skin preparation was done with 10% povidone iodine.All the catheters were inserted under real-time ultrasonographical guidance under strict septic conditions.One patient developed proximal common femoral and iliac dvts (deep venous thrombosis) on day 8 for which the catheter was removed and started on therapeutic anticoagulation.The patient subsequently suffered sudden cardiac arrest likely due to pulmonary thromboembolism.The authors did not provide any additional details of the patient¿s status post cardiac arrest.The authors reported that six patients (31.5%) died during the study but provide no additional details on the causes or any potential relationship between the device and reported deaths.Additionally, the authors are unable to provide details on which devices contributed to the reported complications.
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