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

Model Number 8888145048P

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 08/11/2023

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, while inserting to the patient (catheter with guide wire and venatrac), the guide wire that was included on the reported kit opened at the distal end (guide wire unraveled).There was no luer adapter issue.There was no leak observed at the time of the event.There was no damage to the outer packaging and inner packaging.The sterile barrier was intact.There was nothing unusual observe on the device prior to opening the package and prior to use.Flushing was done prior to use and there was no problem.There were no other visible defects/damages found on the product.The insertion site was treated with clorhex prior to product placement.The cleaning agent used on the device was ¿corhexidina¿.There were no other products utilized with the device.No excessive force was used on the device.The guidewire was removed by hand and there were no tools used when trying to remove the guidewire.It was stated that it was necessary to remove the guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect.When removed the guidewire was still intact (did not break apart).As a remedial action the reported product was changed.The procedure was completed.There was no medical intervention/treatment done to the patient as a result of the event.There was no blood loss.Blood transfusion was not required due to the event.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: 18041690
• MDR Text Key: 327431061
• Report Number: 3009211636-2023-00301
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521158153
• UDI-Public: 10884521158153
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K123196
• 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
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145048P
• Device Catalogue Number: 8888145048P
• Device Lot Number: 2228000093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Date Device Manufactured: 10/18/2022
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 59 KG