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

Model Number 8888145015

Device Problems Insufficient Flow or Under Infusion (2182); Defective Component (2292); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

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, during normal use, there was a low flow, arterial and venous pathways did not function properly and it was mentioned that arterial route did not work properly sometimes.There was no leak.The reported catheter was one of the lot numbers that was being recalled.The catheter was inserted on (b)(6) 2022 and the insertion location was vjid (right internal jugular vein).On (b)(6) 2022, the last kt/v (clearance of urea - dialysis time and volume of distribution of urea) was 1.68.Blood pump flow was 300 (milliliter) ml/minute and effective flow was 280 (milliliter) ml/minute.Quantity of short stay catheters was 6 and placement sites were 1 vjid (right internal jugular vein) , 3 vjie (left internal jugular vein) and 2 vfd (right femoral vein).Quantity of long stay catheter was 1 and placement site was vjid (right internal jugular vein).The catheter was not repaired.It was stated that alteplase thrombolytic was needed once for low flow issue as an intervention.There were no complications on the patient and the ev ent did not lead to or extend patient hospitalization.There was no reported patient injury.

Manufacturer Narrative

Additional information: a2, a4(weight in lbs), b5, g3, h6 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, during the start of the hemodialysis treatment, there was a low flow, arterial and venous pathways did not function properly, and it was mentioned that sometimes the arterial route did not work properly.There was no leak, no luer adapter issue, the line was hard to flush with the syringe, there was no problem with the catheter¿s dimension, there was nothing unusual observe on the device prior to use and there was an occlusion due to the thrombosis.There were no other defects/damages found on the product.The reported catheter was one of the lot numbers that were being recalled (fa1244).The catheter was inserted on june 9, 2022 and the insertion location was vjid (right internal jugular vein).The last kt/v (clearance of urea - dialysis time and volume of distribution of urea) was 1.68 on july 01, 2022.Blood pump flow was 300 (milliliter) ml/minute and effective flow was 280 (milliliter) ml/minute.Quantity of short stay catheters was 6 and placement sites were 1 vjid (right internal jugular vein), 3 vjie (left internal jugular vein) and 2 vfd (right femoral vein).Quantity of long stay catheter was 1 and placement site was vjid (right internal jugular vein).Tego was not utilized, no other products were utilized with the device, no excessive force was used on the device, and the catheter was not repaired.It was stated that alteplase thrombolytic was needed once for low flow issue as an intervention.Aside from the needed alteplase thrombolytic for the catheter there was no other remedial action performed.There was no medical treatment/ intervention provided to the patient as a result of the event.There were no complications on the patient and the event did not lead to or extend patient hospitalization.There was an unspecified amount of blood loss and blood transfusion was not required.There was no reported patient injury.

• 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: 15250396
• MDR Text Key: 305417372
• Report Number: 3009211636-2022-00226
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013169
• UDI-Public: 20884521013169
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 2124600252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG