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

Model Number 8888145015P

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

According to the reporter, during the procedure, the guidewire in the dialysis catheter installation kit presented difficulty sliding through the introducer as well as into the vein.The healthcare team therefore chose to remove the needle and the guidewire in order to start the process again with the same material after rinsing it.During the second trial, the same difficulty was noted, which resulted in the definitive removal of the introducer and the guidewire.After the removal of the defective devices, when the teams wanted to remove the guidewire from the allegedly defective introducer, this first one was "frayed" (sealed) and could not be separated from the introducer in its entirety.The catheter was not repaired.There was no leak and no luer adapter issue.Tego was not utilized.The insertion site was treated prior to product placement.The operation took more time and was extended.There was a replacement with a new introducer and satellite guidewire.The dialysis catheter that came with the introducer and the guidewire concerned with this declaration could be placed.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.

Manufacturer Narrative

Additional information: g3 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 procedure, while inserting the device into the patient, the guidewire in the dialysis catheter installation kit presented difficulty in sliding through the introducer as well as into the vein.The healthcare team therefore chose to remove the needle and the guidewire from the patient in a single action in order to start the process again with the same material after rinsing it.During the second trial, the same difficulty was noted, which resulted in the definitive removal of the introducer and the guidewire.The guidewire was removed from the patient by hand.It was not intact and was frayed after being removed from the patient, but it was not known if it was separated into several pieces or not.After the removal of the defective devices, when the teams wanted to remove the guidewire from the allegedly defective introducer, it could not be separated from the introducer in its entirety, but when the guidewire was removed from the introducer, the introducer was frayed.There was nothing unusual observed on the device prior to use.Besides the reported issue, there were no other visible defects/damages found on the product.There was no problem with the catheter's dimension.It was stated that the initial rinsing (flushing) was unknown, and following slippage difficulties, the equipment was rinsed.There was no leak and no luer adapter issue.Tego was not utilized, and there were no other products utilized with the device.There was no excessive force used on the device.The catheter was not repaired.There was no cleaning agent used on the device.The insertion site was treated with povidone prior to product placement.The operation took more time and was extended.There was a replacement with a new introducer and satellite guidewire (with unknown information) on the same day of the event to resolve the issue.The dialysis catheter that came with the introducer and the guidewire concerned with this declaration (catheter within the kit) was inserted or implanted into the patient on the same date as the event.The procedure was completed.There was no blood transfusion required due to the event.There was no medical intervention/treatment 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: 18144501
• MDR Text Key: 329352954
• Report Number: 3009211636-2023-00308
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521157989
• UDI-Public: 10884521157989
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015P
• Device Catalogue Number: 8888145015P
• Device Lot Number: 2305800166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Date Device Manufactured: 03/03/2023
• 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