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

Model Number	8888145016
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
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, during use, the catheter had a low flow issue.It was said that there was a presence of clots when aspirating both routes/pathways.Arterial pathway did not function properly.It was said that alteplase 1 time was required.Blood pump flow was 180 ml/min and effective flow was 150 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.02 on (b)(6) 2022.It was said that the placement site was in vjid (right internal jugular vein).The catheter was not repaired and had no leak.There was no luer adapter issue.It was also stated that the device was a recalled product (recall fa1244).Quantity of short and long stay catheters that the patient had used were both one with placement sites vjid (right internal jugular vein).There were no clinical complications.There was no other medical or surgical intervention needed to prevent a permanent impairment.The event did not lead to or extend patient hospitalization.There was no reported patient injury.
Event or Problem Description
According to the reporter, during use, the catheter had a low flow issue.It was said that there was a presence of clots when aspirating both routes/pathways.Arterial pathway did not function properly.It was said that alteplase 1 time was required.Blood pump flow was 180 ml/min and effective flow was 150 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.02 on (b)(6) 2022.It was said that the placement site was in vjid (right internal jugular vein).Nothing unusual was observed on the device prior to use.No defects/damages were found on the product (crack, cut, etc.).The catheter was not repaired and had no leak.There was no luer adapter issue.The line was hard to flush with the syringe.No other products were being utilized with the device.It was also stated that the device was a recalled product (recall fa1244).Quantity of short and long stay catheters that the patient had used were both one with placement sites vjid (right internal jugular vein).There was a blood loss.There were no clinical complications.There was no other medical or surgical intervention needed to prevent a permanent impairment.The event did not lead to or extend patient hospitalization.There was no reported patient 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.
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, during use, the catheter had a low flow issue.It was said that there was a presence of clots when aspirating both routes/pathways.Arterial pathway did not function properly.It was said that alteplase 1 time was required.Blood pump flow was 180 ml/min and effective flow was 150 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.02 on (b)(6) 2022.It was said that the placement site was in vjid (right internal jugular vein).Nothing unusual was observed on the device prior to use.No defects/damages were found on the product (crack, cut, etc.).The catheter was not repaired and had no leak.There was no luer adapter issue.The line was hard to flush with the syringe.No other products were being utilized with the device.It was also stated that the device was a recalled product (recall fa1244).Quantity of short and long stay catheters that the patient had used were both one with placement sites vjid (right internal jugular vein).There was an unknown amount of blood loss.There were no clinical complications.There was no other medical or surgical intervention needed to prevent a permanent impairment.The event did not lead to or extend patient hospitalization.There was no reported patient injury.

• 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: 15241350
• Report Number: 3009211636-2022-00219
• Device Sequence Number: 6446941
• Product Code: MSD
• UDI-Device Identifier: 10884521013179
• UDI-Public: 10884521013179
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2024
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 1915800095
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 09/14/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/06/2022; 09/30/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 86 KG