MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products:¿ 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.

Event Description

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.Reported complications included catheter-related infection in 3 patients where the catheter had to be removed and 3 cases of catheter-related deep venous thrombosis (dvt).Two other patients developed iliac and femoral vein thrombosis that extended into the inferior vena cava at 1 month for which the catheters were removed and anticoagulation was started.Patients with probable catheter-related blood stream infections were started on intravenous vancomycin and piperacillin tazobactam that was later modified as per the blood culture sensitivity report.Patients who presented with limb edema after catheterization, a duplex ultrasonography was done for deep venous thrombosis and were anticoagulated with warfarin after catheter removal.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15792357
• MDR Text Key: 303627502
• Report Number: 3009211636-2022-00400
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR