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); Fungal Infection (2419); Thrombosis/Thrombus (4440); Drug Resistant Bacterial Infection (4553)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: unk dy, dialysis unknown (lot#: unknown); unk dy, dialysis unknown (lot#: unknown) richa prakash, alpana ohri, amish udani, uma sankari ali.Survival of tunneled double lumen-cuffed catheters in children on maintenance hemodialysis: a retrospective cohort study.Indian journal of nephrology, volume 33, issue 5.Doi: 10.4103/ijn.Ijn_37_22.Pages 348-355 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 cohort study from (b)(6) 2018 was undertaken to determine the infection free survival rate of tunneled cuffed catheters (tcc), the incidence and causes of catheter failure, and the associated risk factors in children undergoing maintenance hemodialysis through tunneled catheters.Forty-five (45) tccs were inserted in patients between the ages of 5 and 16.Either a silicone mahurkar catheter in sizes 8, 10, or 12.5 french was used or a competitor device.Serious complications included infection in 15 patients where the organism of infection was either gram negative bacilli, klebsiella, pseudomonas, methicillin-resistant staphylococcus aureus (mrsa), citrobacter, acinetobacter, or candida glabra.Infections were treated with either antibiotics or catheter removal.If at 72 hour, the patient was afebrile and hemodynamically stable.Thrombosis occurred in 13 patients.Thrombosis was treated with either urokinase locking solutions, recombinant-urokinase infusions, or catheter removal.The authors did not provide information on which reported adverse events were related to mahurkar catheters or a competitor device.

Event Description

According to the literature, a retrospective cohort study from september 1 2012 to september 31 2018 was undertaken to determine the infection free survival rate of tunneled cuffed catheters (tcc), the incidence and causes of catheter failure, and the associated risk factors in children undergoing maintenance hemodialysis through tunneled catheters.Forty-five (45) tccs were inserted in patients between the ages of 5 and 16.Either a silicone mahurkar catheter in sizes 8, 10, or 12.5 french was used or a competitor device.Serious complications included infection in 15 patients where the organism of infection was either gram negative bacilli, klebsiella, pseudomonas, methicillin-resistant staphylococcus aureus (mrsa), citrobacter, acinetobacter, or candida glabra.Infections were treated with either antibiotics or catheter removal.If at 72 hour, the patient was afebrile and hemodynamically stable.Thrombosis occurred in 13 patients.Thrombosis was treated with either urokinase locking solutions, recombinant-urokinase infusions, or catheter removal.The health impact were failure of implant and drug resistant bacterial infection.The authors did not provide information on which reported adverse events were related to mahurkar catheters or a competitor device.Pli 30: according to the literature, a retrospective cohort study from september 1 2012 to september 31 2018 was undertaken to determine the infection free survival rate of tunneled cuffed catheters (tcc), the incidence and causes of catheter failure, and the associated risk factors in children undergoing maintenance hemodialysis through tunneled catheters.Forty-five (45) tccs were inserted in patients between the ages of 5 and 16.Either a silicone mahurkar catheter in sizes 8, 10, or 12.5 fr was used or a competitor device.Non-serious complications included 2 kinking and malposition of catheters which were either managed with guide wire manipulation or catheter removal and 3 catheters that were cracked were removed immediately and replaced with another catheter at the same or different site.Routine catheter care was performed at the end of each dialysis session.The exit site was cleaned with a solution of 2.5% chlorhexidine in alcohol followed by a sterile transparent dressing of the exit site that was changed weekly unless indicated earlier.The catheter was locked with heparin in a concentration of 5000 units per milliliter.The authors did not provide information on which reported adverse events were related to mahurkar catheters or a competitor device.

Manufacturer Narrative

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: 18499835
• MDR Text Key: 332724533
• Report Number: 3009211636-2024-00020
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 12/27/2023
• 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
• Treatment: SEE NOTE ON H10
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 10 YR
• Patient Sex: Male