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

Model Number 8888119364P

Device Problem Material Fragmentation (1261)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

According to the reporter, while inserting the catheter and sheath being pulled apart, the pull apart sheath handles just simply broke off leaving the tube portion in the patient's neck.There was just an issue continuing with the procedure as the pull apart sheath was already in motion of pulling apart with entry of catheter which made it difficult to continue to insert the catheter.Again, the issue was the wings or handles of the pull apart sheath broke off while inserting the catheter down the inner lumen.The catheter was not repaired and there was no leak.There was no cleaning agent used on the device.Tego was not utilized and there was no luer adapter issue.The pull apart sheath was the one included in the catheter kit.There was nothing unusual observed on the device prior to use and no damages were found on pull apart sheath.There were no other products utilized aside from the products inside the catheter sport pack.The catheter was flushed with normal result but information was not provided of flushing the pull apart sheath.They were able to push the catheter down and able to complete the pull apart sheath to resolve the issue.The sheath was not replaced with a new device and procedure was completed.It was stated that the sheath's tube portion that was left from the patient's neck was pulled out manually without any handles and were able to retrieve completely and nothing was left in the body or nothing fell in the body.There were no procedures performed to check for the retained portion and x-ray machine was not used.The case was completed fully with initial catheter sportpack and no replacement needed then the product was discarded.There was no blood loss and blood transfusion was not required.There was no medical intervention needed as a result of the event.There were no current and pre-existing conditions of the patient that may be related to the event.The event did not lead to patient having a vessel damage and hospitalization.There was no patient harm.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: 17761448
• MDR Text Key: 324009049
• Report Number: 3009211636-2023-00256
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521157705
• UDI-Public: 10884521157705
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888119364P
• Device Catalogue Number: 8888119364P
• Device Lot Number: 2228000076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Date Device Manufactured: 01/18/2023
• 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