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, the catheter had low flow and needed alteplase thrombolytic.The placement site of the long stay catheter was vjid (right internal jugular vein).The flow of blood pump was 200 ml/min (milliliter/minute) and the effective flow was 180 ml/min.There was no leak and no luer adapter issue.The catheter was not repaired.On (b)(6) 2022 the last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.47.There was no clinical complications.The event did not lead to or extend patient hospitalization.There was no reported patient injury.

Event Description

According to the reporter, during hemodialysis, the catheter had low flow and needed alteplase thrombolytic.The reported catheter was part of a recall (fa1244).The quantity of short stay catheter was one and the placement site was vjid (right internal jugular vein).The quantity of long stay catheter was 1 and the placement site was vjid (right internal jugular vein).It was stated that the reported catheter was inserted last (b)(6)2022 and the insertion location was vjid (right internal jugular vein).The flow of blood pump was 200 ml/min (milliliter/minute) and the effective flow was 180 ml/min.There was no leak and no luer adapter issue.The catheter was hard/difficult to flush with the syringe, and there was an occlusion due to thrombosis.Tego was not utilized, and the catheter was not repaired.The last kt/v (k- dialyzer clearance of urea, t- dialysis time, v- volume of distribution of urea) was 1.47 on (b)(6), 2022.It was mentioned that the reported catheter remained to have low flow and alteplase was already required once.Aside from the thrombolytic alteplase there were no other corrective action taken.Aside from alteplase needed for the catheter, there was no medical treatment/ intervention provided to the patient as a result of the event.The event did not lead to or extend patient hospitalization.There was an unspecified amount of blood loss.There were no clinical complications.There was no reported patient injury.

Manufacturer Narrative

Additional information: b2, b4, b5, d6a, 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.

• 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: 15241449
• MDR Text Key: 303929489
• Report Number: 3009211636-2022-00224
• 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: Physician
• 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: 08/17/2022
• 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: 08/19/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 61 KG