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

Model Number	8888123404P
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the reporter, the catheter was implanted in the patient under 1 year, during dialysis run, air was pulled into the catheter through a small hole in the arterial limb of the catheter which created bubbles in the dialysis circuit, causing the patient to have to come from trail to hospital for an immediate admission and replacement.The catheter was not repaired and there was a fluid/blood leak found at the shaft during flushing.There was no leak at the junction of the bifurcate and the catheter.Tego was utilized.Chlorhexidine with alcohol was the cleaning agent used on the device.There was no luer adapter issue.Clamps were moved to a new location after each treatment.Flushing was done prior to use and it was discovered that there was a leak issue.Tego <(>&<)> 3m tegaderm iv advanced were utilized with the device aside from circuit.The exit site was not treated with any medication.3m tegaderm iv advance was the wound dressing used to the patient.The wound dressing did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no ointment utilized.The patient was not responsible for any type of catheter maintenance.Cleaning agent was never switched over the life of the catheter and it was never mixed.Sepsiderm was not used to clean the device.There was no change in protocol for cleaning agents used.After catheter replacement, the issue was resolved.Treatment was completed.There was no blood loss and blood transfusion was not required.The patient did not hospitalized.The event did not result to patient having symptoms, infections and complications.There were no other intervention/treatment required as a result of the event.
Event or Problem Description
According to the reporter, the catheter was implanted in the patient under 1 year, during dialysis run, air was pulled into the catheter through a small hole in the arterial limb of the catheter which created bubbles in the dialysis circuit, causing the patient to have to come from trail to hospital for an immediate catheter replacement.The catheter was not repaired and there was a fluid/blood leak found at the shaft during flushing.There was no leak at the junction of the bifurcate and the catheter.Tego was utilized.Chlorhexidine with alcohol was the cleaning agent used on the device.There was no luer adapter issue.Clamps were moved to a new location after each treatment.Flushing was done prior to use and it was discovered that there was a leak issue.Tego <(>&<)> 3m tegaderm iv advanced were utilized with the device aside from circuit.The exit site was not treated with any medication.3m tegaderm iv advance was the wound dressing used to the patient.The wound dressing did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no ointment utilized.Patient was not responsible for any type of catheter maintenance.Cleaning agent was never switched over the life of the catheter and it was never mixed.Sepsiderm was not used to clean the device.There was no change in protocol for cleaning agents used.After catheter replacement, the issue was resolved.Treatment was completed.There was no blood loss and blood transfusion was not required.The p atient did not hospitalized.The event did not result to patient having symptoms, infections and complications.There was no other intervention/treatment required aside from catheter replacement which had to be completed urgently.
Additional Manufacturer Narrative
Additional information: b2 (removed hospitalization), b5, g3, h6: removed fdp (hospitalization or prolonged hospitalization) and imf (hospitalization).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.
Additional Manufacturer Narrative
Additional information: b5, g3 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 or Problem Description
According to the reporter, the catheter was implanted in the patient under one year, during dialysis run, air was pulled into the catheter through a small hole in the arterial limb of the catheter which created bubbles in the dialysis circuit, causing the patient to have to come from trail to hospital for an immediate admission and replacement.The catheter was not repaired and there was a fluid/blood leak found at the shaft during flushing.There was no leak at the junction of the bifurcate and the catheter.Tego was utilized.Chlorhexidine with alcohol was the cleaning agent used on the device.There was no luer adapter issue.Clamps were moved to a new location after each treatment.Flushing was done prior to use and it was discovered that there was a leak issue.Tego <(>&<)> 3m tegaderm iv advanced were utilized with the device aside from circuit.The exit site was not treated with any medication.3m tegaderm iv advance was the wound dressing used to the patient.The wound dressing did not include any cleaning agents or antimicrobial properties.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.There was no ointment utilized.The patient was not responsible for any type of catheter maintenance.Cleaning agent was never switched over the life of the catheter and it was never mixed.Sepsiderm was not used to clean the device.There was no change in protocol for cleaning agents used.After catheter replacement, the issue was resolved.Treatment was completed.There was no blood loss and blood transfusion was not required.The patient did not hospitalized.The event did not result to patient having symptoms, infections and complications.There was no other intervention/treatment required aside from catheter replacement which had to be completed urgently.

• Brand Name: PALINDROME
• Common Device Name: 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: 16074681
• Report Number: 3009211636-2022-00460
• Device Sequence Number: 12330970
• Product Code: MSD
• UDI-Device Identifier: 10884521157774
• UDI-Public: 10884521157774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Model Number: 8888123404P
• Device Catalogue Number: 8888123404P
• Device Lot Number: 2119300073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 02/03/2023; 02/22/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/20/2023; 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown