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

Model Number DIALYSIS UNKNOWN

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 12/04/2022

Event Type  Injury  

Event Description

According to the literature, a retrospective study from 2015 to 2020 evaluated the association between tunneled central venous catheter (tcvc) and mortality among elderly hemodialysis (hd) patients in a long-term care hospital.A total of 463 patients were included in the study: 369 patients with non-tcvc access for dialysis and 53 patients with a tcvc that was either a palindrome precision symmetric tip dialysis catheter, or a competitor device.Reported complications associated with the catheter included 4 instances of catheter dysfunction and 2 cases of catheter-related infection.It was also stated that it was unable and hard to insert or decannulation the device, so it was a case where re-implantation or decannulation were attempted.It was also unable to remove, and had sepsis which on page 5, in table 2."sepsis, n (%) 3 (5.7)", so it was determined to be sepsis and based on a review of the article.Tcvc's were inserted in the right internal jugular vein, followed by the left internal jugular vein and the right femoral vein.A competitors plug was attached to the catheter's connection.Disinfection of the catheter ports was performed using ethanol cotton before connecting the catheter to the circuit at the start of hd and locking the catheter at the end of hd.Catheter locking was routinely performed with 5,000 u/5 ml (each catheter lumen, 2,500 u/2.5 ml) of heparin after flushing with 20 ml (each catheter lumen, 10 ml) of saline at the end of hd thrice weekly.The catheter dressing change at the exit site was performed once weekly and included cleansing of the exit site with a 0.2% chlorhexidine cotton ball and applying a sterile dry gauze dressing.No defects/damages/issues found on the product.Nothing unusual observed prior to use.Another company's product being utilized with the devices.Interventions related to these complications included removal and replacement of the catheters.No other interventions were reported.The article also included a total of 45 deaths.However, the authors indicated that the deaths were unrelated to the catheter but instead were ¿associated with age, dialysis vintage, male sex, charlson comorbidity index (cci), and serum albumin level but were not associated with tcvc.¿.

Manufacturer Narrative

Title: the impact of tunneled central venous hemodialysis catheter on mortality of elderly hemodialysis patients hospitalized in a long-term care hospital source: hemodialysis ¿ research article | blood purif 2023;52:392¿400 | doi: 10.1159/000528575 | published online: january 12, 2023 | masataka banshodani, seiji marubayashi, yusuke kawai, shinji hashimoto, sadanori shintaku, misaki moriishi, shinichiro tsuchiya, hideki kawanishi 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: 17298620
• MDR Text Key: 318833217
• Report Number: 3009211636-2023-00197
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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: 06/26/2023
• 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