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

Model Number DIALYSIS UNKNOWN

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

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

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

Reference: sertan özyalçin, 2023.The impact of spontaneous echo contrast on tunneled dialysis catheter patency.The journal of vascular access 2023, vol.24(3) 423¿429.Sagepub.Com/journals-permissions doi: 10.1177/11297298211035599.Journals.Sagepub.Com/home/jva accepted: 8 july 2021.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 prospective study of (b)(4) patients who underwent a tunneled dialysis catheter (tdc) placement with the h-heparin coated dialysis catheter in a cardiovascular surgery clinic between (b)(6) 2015 and (b)(6) 2020 were examined to investigate the impact of spontaneous echo contrast (sec) detected during tdc insertion on the patency of the catheter.In all patient, the tdc insertion procedure was performed under ultrasound guided fluoroscopy.The aim of the study was also to assess whether sec images detected during the tdc insertion procedure has an effect on the durability and function of the catheter in patients in whom tdc was placed in the right internal jugular vein (ijv).Since the sec grade may vary depending on the area of intervention, only first tdc inserted in the right ijv were included in the study.The (b)(4) patients whose catheter was removed due to catheter infection during follow-up were also excluded.The endpoint of the study was the development of either tdc thrombosis or tdc infection.Based on the set criteria, (b)(4) patients were included in the study and were divided in five groups.The patients were divided into five groups according to their sec grades revealed by ultrasonographic findings during the procedure.(sec0¿4) patients¿ demographic data, medical history, hemoglobin, platelet, and fibrinogen levels before the procedure, and echocardiography findings before the intervention were examined.During the follow-up period, the first time of catheter thrombosis was recorded and evaluated.Catheter thrombosis was defined as absence blood flow from one or both lumen of the catheter, or failure to achieve blow flow >250 ml/min during two consecutive sessions without anatomical position disorder in the catheter.It was stated that sec grade was found to be a significant risk factor for catheter thrombosis.Higher sec grades were significantly correlated with faster catheter thrombosis postinsertion.The article did not provide any information on interventions required for the treatment of catheter infection or thrombosis.

• 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: 18037106
• MDR Text Key: 326910807
• Report Number: 3009211636-2023-00299
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Female