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	Thrombosis/Thrombus (4440)
Date of Event	03/15/2022
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 first inserted on (b)(6) and the insertion site was at the (vfd) right femoral vein.On (b)(6), it was said that the catheter had low flow issues, arterial/venous pathways did not function properly and alteplase thrombolytic agent was needed as medical intervention due to the event.Also, there was a deep vein thrombosis of left lower limb.On (b)(6), the catheter was changed.Blood pump flow was 280 ml/min and effective flow was 250 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.74 on (b)(6) 2022.The catheter was not repaired and had no leak.Quantity of short stay catheters that the patient had used were seven with placement sites 1 vscd (right subclavian vein), 3 vjid (right internal jugular vein), 1 vfd (right femoral vein) and 2 vfe (left femoral vein) while the quantity of long stay catheters that the patient had used were four with placement sites 1vjid (right internal jugular vein), 1vfd (right femoral vein) and 2 vfe (left femoral vein).Additionally, the catheter was a recalled product under recall fa1244.The event did not lead to or extend patient hospitalization.
Additional Manufacturer Narrative
Additional information: a2, a3, b2, b5, d10, g3 d10: 8888145015 23/40cmpalindrome kit wslot (lot#173470011) 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 first inserted on (b)(6) and the insertion site was at the (vfd) right femoral vein.On (b)(6), during the start of hemodialysis, it was said that the catheter had low flow issues, arterial/venous pathways did not function properly and alteplase thrombolytic agent was needed as medical intervention due to the event which resolved the issue.Also, there was a deep vein thrombosis of left lower limb.On (b)(6), the catheter was changed.Blood pump flow was 280 ml/min and effective flow was 250 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.74 on (b)(6) 2022.The catheter was not repaired and had no leak.It was said that the line was difficult to wash with syringe.No visible defects or damage were found in the "venous pathway" where the low flow was observed.No visible defects/damage were found on the product.Tego was not utilized and there was no luer adapter issue.No other products were being used with the device.There was a blood loss but no blood transfusion was required.Dialysis treatment was not completed.Quantity of short stay catheters that the patient had used were seven with placement sites 1 vscd (right subclavian vein), 3 vjid (right internal jugular vein), 1 vfd (right femoral vein) and 2 vfe (left femoral vein) while the quantity of long stay catheters that the patient had used were four with placement sites 1vjid (right internal jugular vein), 1vfd (right femoral vein) and 2 vfe (left femoral vein).Additionally, the catheter was a recalled product under recall fa1244.The event did not lead to or extend patient hospitalization.
Event or Problem Description
According to the reporter, the catheter was first inserted on (b)(6) and the insertion site was at the (vfd) right femoral vein.On (b)(6), during the start of hemodialysis, it was said that the catheter had low flow issues, arterial/venous pathways did not function properly and alteplase thrombolytic agent was needed as medical intervention due to the event which resolved the issue.Also, there was a deep vein thrombosis of left lower limb.On (b)(6), the catheter was changed.Blood pump flow was 280 ml/min and effective flow was 250 ml/min.Last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.74 on (b)(6) 2022.The catheter was not repaired and had no leak.It was said that the line was difficult to wash with syringe.No visible defects or damage were found in the "venous pathway" where the low flow was observed.No visible defects/damage were found on the product.Tego was not utilized and there was no luer adapter issue.No other products were being used with the device.There was an unknown amount of blood loss but no blood transfusion was required.Dialysis treatment was not completed.Quantity of short stay catheters that the patient had used were seven with placement sites 1 vscd (right subclavian vein), 3 vjid (right internal jugular vein), 1 vfd (right femoral vein) and 2 vfe (left femoral vein) while the quantity of long stay catheters that the patient had used were four with placement sites 1vjid (right internal jugular vein), 1vfd (right femoral vein) and 2 vfe (left femoral vein).Additionally, the catheter was a recalled product under recall fa1244.The event did not lead to or extend patient hospitalization.
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.

• 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: 15241419
• Report Number: 3009211636-2022-00223
• Device Sequence Number: 14626014
• 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?: Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 47 KG