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

Model Number 8888145044

Device Problem Material Deformation (2976)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/17/2023

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 patient underwent intracervical tunneled cuffed catheter (tcc) on the right neck on the day of the event, and a re-examination of the chest radiograph (post-operative chest x-ray) showed that the catheter that was included in the kit was wrinkled after the surgery.The flow rate during the dialysis process was still acceptable.At that time, it was considered whether there was tissue or fascia stretching that caused the catheter to deform.There was nothing unusual observed on the device prior to use.There were no other visible defects/damages found on the product.There was no leak and no luer adapter issue.Flushing was done prior to use with a normal result.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 was not treated prior to product placement.The catheter was not repaired.On the second day after the surgery, the catheter was adjusted again to resolve the issue, and the fascia and tissue at the deformed part were fully separated.After it was confirmed that the catheter was not stretched or compressed, and that there were no folds on the surface of the catheter, it was sutured.The chest x-ray was checked again, and the folds did not change.The dialysis test was performed again and the catheter flow was available.It was also mentioned that the internal structure problem of the catheter was considered.There was no delay in the treatment as a result of the issue.The treatment was completed after the issue was resolved.There was no blood loss due to the event, and blood transfusion was not required.Aside from chest radiograph and adjusting the catheter again, there was no other medical intervention/treatment provided to the patient due to the event.

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 patient underwent intracervical tunneled cuffed catheter (tcc) on the right neck on the day of the event, and a re-examination of the chest radiograph (post-operative chest x-ray) showed that the catheter that was included in the kit was wrinkled after the surgery.The flow rate during the dialysis process was still acceptable.At that time, it was considered whether there was tissue or fascia stretching (traction) that caused the catheter to deform.There was nothing unusual observed on the device prior to use.There were no other visible defects/damages found on the product.There was no leak and no luer adapter issue.Flushing was done prior to use with a normal result.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 was not treated prior to product placement.The catheter was not repaired.On the second day after the surgery, the catheter was adjusted again to resolve the issue, and the fascia and tissue at the deformed part were fully separated.After it was confirmed that the catheter was not stretched or compressed, and that there were no folds or no wrinkling on the surface of the catheter, it was sutured (sealing required post-operation).The chest x-ray was checked again, and the folds did not change.The dialysis test was performed again and the catheter flow was available.It was also mentioned that the internal structure problem of the catheter was considered.There was no delay in the treatment as a result of the issue.The treatment was completed after the issue was resolved.There was no blood loss due to the event, and blood transfusion was not required.Aside from chest radiograph and adjusting the catheter again, there was no other medical intervention/treatment provided to the patient due to the event.

• 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: 17783386
• MDR Text Key: 323862982
• Report Number: 3009211636-2023-00260
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112477
• 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
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 2230000157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2023
• Date Device Manufactured: 12/10/2022
• 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: 24 YR
• Patient Sex: Male