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	03/30/2022
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, at the start of hemodialysis session, there was low flow, arterial and venous pathways did not function properly and there was venous thrombosis.The line was difficult to wash with the syringe.The reported catheter was one of lot numbers that were being recalled (under fa1244).The place of insertion was at the vfd (right femoral vein).Last kt/v (date) (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.01 on (b)(6) 2022.Blood pump flow was 150 ml/min.Effective flow was 100 ml/min.Nothing unusual observed on the device prior to use.No other products being utilized with the device.No other defects/damage found in the product.Tego was not utilized.The catheter was not repaired, no luer adapter issue and there was no leak.Quantity of short stay catheters that the patient had used was 6, 2 at the vjid (right internal jugular vein), 2 at the vjie (left internal jugular vein) and 2 at the vfe (left femoral vein).Quantity of long stay catheters that the patient had used was 2, 1 at the vfd (right femoral vein), and 1 at the vfd (right femoral vein).The catheter was changed on 7/9 and the place of insertion was at the vfe (left femoral vein).The event did not lead to or extend patient hospitalization.Clinical complication was deep vein thrombosis in the right lower limb on (b)(6) 2022.Venous thrombosis required the use of alteplase thrombolytic once as intervention.Anticoagulation was used specifically for the patient.There was unspecified amount of blood loss and blood transfusion was not required.The patient died.It is not know if the device was still implanted or in use when the patient passed away.
Additional Manufacturer Narrative
Concomitant medical products: 8888145015 23/40cmpalindrome kit wslot (lot#2201000063).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: 15294178
• Report Number: 3009211636-2022-00246
• Device Sequence Number: 12310111
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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
• Initial Report FDA Received Date: 08/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown