MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145015

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2023

Event Type  Injury  

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.

Event Description

According to the reporter, the catheter was implanted in the body for a month, but after treatment, the cuff failed to integrate or did not grow well with the skin tissue, resulting in partial detachment of the extension tube, the cuff fell off and was exposed, purulent wound infection, and pus discharge.It was stated that it was not a bacterial infection.Nothing unusual was observed on the device prior to use.Flushing was not done prior to use.There were no other abnormalities found in the product.There was no leak.There was no luer adapter issue.Tego was not used.There were no other products utilized with the device.No excessive force was used on the device.No cleaning agent was used on the device.The skin or the insertion was disinfected and treated with iodophor according to sanitizing practices.A tube replacement was done to resolve the issue.The treatment was not completed after resolving the issue.There was no blood loss.A blood transfusion was not required due to the event.The medication/intervention provided to the patient's wound infection and pus discharge were disinfection with with iodophor gauze and dried with mupirocin for external application.The patient was investigated for diabetes history, etc., but there were no related diseases.The patient had no health problems at this time right after the event.Aside from wound infection and pus discharge, there was no other patient injury due to the event.

Manufacturer Narrative

H6 patient codes - e2402 (failed to integrate with skin tissue).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 reporter, the catheter was implanted in the body for a month, but after the treatment, the cuff failed to integrate or did not grow well with the skin tissue, which caused the extension tube to be partially detached, the cuff fell off and was exposed, purulent wound infection, and pus discharge.It was stated that it was not a bacterial infection.There was nothing unusual observed on the device prior to use.Flushing was not done prior to use.There were no other visible defects/damages found on the product.There was no leak.There was no luer adapter issue.Tego was not utilized, and there were no other products utilized with the device.There was no excessive force used on the device.There was no cleaning agent used on the device.The insertion site or the skin was disinfected or treated with iodophor prior to product placement according to the disinfection regulations.A tube replacement was done to resolve the issue.The treatment was not completed after resolving the issue.There was no blood loss, and a blood transfusion was not required due to the event.The medication/intervention provided for the patient's wound infection and pus discharge were disinfection with iodophor gauze and dried with mupirocin for external application.It was checked whether the patient had a diabetes history, etc., but there were no related diseases.The patient had no health problems at this time, right after the event.A side from wound infection and pus discharge, there was no other patient injury due to the event.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The evaluation found no potentially contributing factors.It was reported that the adverse event with no identified issue, the device cuff was detached from catheter and extension tube was detached from bifurcate.The reported issues were not confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 18419557
• MDR Text Key: 331619027
• Report Number: 3009211636-2023-00373
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 2314400131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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): Other; Required Intervention