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); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: unk dy, dialysis unknown, (lot # unknown) author: biser borisov, md, phd.Title: hemodialysis tunneled catheters lock with taurolock¿ versus a combination of gentamycine and heparine source: https://doi.Org/10.5272/jimab.2023293.5045.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 a literature, the aim of the study was to determine the incidence of these complications in patients who underwent ¿locking¿ of the tunneled catheters and compare the cost of different options with their effect.A study of 45 patients (twenty-three men and twenty-two women) from october 10, 2021 to march 31, 2022 evaluated the incidence of catheter-related infections and thrombosis in patients whose tunneled catheters were locked using taurolock, gentamicin and heparin, or a combination of both.The tunneled catheters used in the patients were 14.5 french palindrome symmetric tip dual lumen catheter, 28cm carbothane and competitor devices.The patients were randomly divided into three groups of 15 people each: group a ¿ locking the catheter only with taurolock; group b ¿ locking with gentamicin (10 mg/ml) and heparin (1250 iu/ml) and group c ¿ locking with taurolock for three months, then with heparin and gentamicin for the next three months of the study.The patients were monitored for the major complications of catheter-related infection (cri) and catheter-related thrombosis (crt).All patients had tunneled catheters placed less than 3 months ago as the only vascular access for hemodialysis treatment.The median length of stay for tunneled catheters was 8,105 catheter days.The reported complications included were: group a - one case of catheter related infections-cris (staphylococcus epidermidis) (catheter-associated exit site and subcutaneous tunnel infection) requiring replacement of the tunneled catheter and parenteral treatment with levofloxacin 500mg/daily for 10 days.No cases of catheter-associated bloodstream infection requiring prolonged treatment and catheter thrombosis requiring replacement of the tunneled catheter were reported.The case of catheter-related infection showed no growth from blood culture, staphylococcus epidermidis was isolated from local secretion, the tunneled catheter was replaced over a metal guidewire with the creation of a new tunnel.For groups b and c - one case of catheter-related thrombosis each which required the administration of urokinase 25,000 iu, with good effect.39 patients completed the study, 6 people died due to covid-19 infection and the mean age of those who died was significantly higher than of those who completed the study.The authors did not indicate which catheters were associated with the reported complications.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.No information regarding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that one photo of an infection was provided but the study looked at 3 different kinds of commercially available catheters, and it was not possible to determine which catheter was shown in the photo, nor was it possible to determine the cause of the infection or whether it was the result of any device failure.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 17829235
• MDR Text Key: 324408879
• Report Number: 3009211636-2023-00264
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: BU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male