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

Model Number 8888145062P

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 12/20/2022

Event Type  malfunction  

Event Description

According to the reporter, during dialysis treatment, there was an instance that where the catheter was not running adequately on their hd (hemodialysis) machine due to high pressures or catheter clotting internally and having to be cathflowed.There was nothing unusual observed on the device prior to use, there was no other product utilized and there was no other visible defects/damages found on the product.Flushing was performed with normal result.The catheter was prone to clot, but wanted to be safe, so it was reported.This was the first time that this type of catheter (silver ion coated) was placed at this facility, as they have been using competitor's brand.They have used few of our catheters before and no trouble was reported.They used tego caps and lock with saline and the catheter can be prone to clot.It was mentioned that the catheter had incorrect length and had to get a catheter exchange, but that was not a catheter issue.The catheter was not repaired, there was no leak and there was no luer adapter issue.There was no patient symptoms or complication associated with this event.The treatment was completed and the blood of the patient was safely returned.It was also stated that cathflow and activase (alteplase) were the anticoagulant, and was provided as the intervention/treatment for the internal catheter clotting.The customer tried to reverse the lines and the reverse flow was done successfully in addition to cathflow.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

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
• 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: 16374357
• MDR Text Key: 309655487
• Report Number: 3009211636-2023-00055
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158337
• UDI-Public: 10884521158337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145062P
• Device Catalogue Number: 8888145062P
• Device Lot Number: 2113400096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Date Device Manufactured: 08/21/2021
• 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