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 Bacterial Infection (1735); Septic Shock (2068); Unintended Radiation Exposure (4565)

Event Date 06/06/2023

Event Type  Injury  

Event Description

According to the literature case study, a patient with a past medical history significant for heart failure with reduced ejection fr acture(hfref), alcoholic liver disease with active alcohol use disorder, and end-stage renal disease (esrd) on hemodialysis (hd) was brought to the emergency department on november 9, 2022 because of bizarre behavior.The patient was subsequently admitted to the intensive care unit (icu) because of metabolic encephalopathy suspected to be secondary to severe uremia, which was managed by hd via a right internal jugular (rij) catheter.The patient experienced severe septic shock which required vasopressors to maintain hemodynamic stability.The patient also started on vancomycin and meropenem.The initial urine cultures were positive for escherichia coli (e.Coli), and subsequent blood cultures were positive for pseudomonas putida and streptococcus mutans.The patient was then started on a course of antibiotics including ciprofloxacin 400mg (milligrams) iv (intravenous) and vancomycin 500mg iv after every hd for six weeks under the supervision of the infectious diseases team.Additionally, general surgery assisted with rij permcath decannulation and replaced with a right common femoral trialysis catheter on november 21, 2022.A transesophageal echocardiogram (tee) was performed on november 23, 2022 which showed a ¿string-like material¿ attached to the right atrium and an ejection fraction of 25%.The tunneled rij permcath tip cultures on november 24, 2022 were positive for pseudomonas aeruginosa.The finding was most likely a fibrin sheath from the previous right internal jugular catheter, and it could be associated with a fibrin sheath-associated endovascular infection of the heart in the setting of polymicrobial bacteremia (pseudomonas putida and streptococcus mutans) and positive ca theter tip culture (pseudomonas aeruginosa).The patient recovered from her illness, and at the time of discharge was back at her physiologic baseline.

Manufacturer Narrative

Javier b.Chambi-torres, "fibrin sheath catheter-related endovascular right-sided heart infection in heart failure with reduced ejection fraction: a case report." cureus 15(6): e40060., 2023 doi 10.7759/cureus.40060.Pages 1-6 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.

• 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: 17493967
• MDR Text Key: 320756767
• Report Number: 3009211636-2023-00227
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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: 60 YR
• Patient Sex: Female