MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145039P
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, when the guidewire from the kit was introduced into a temporary catheter, it unraveled upon removal.There was no reported patient outcome.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during the operation, when the guidewire from the kit was introduced into a temporary catheter, the guidewire unraveled upon removal.It was also stated that it uncoiled inside the body.There was not any resistance observed when inserting the guidewire, and there was no tool used when trying to remove it.The guidewire was removed slowly, with no excessive force, to avoid breakage.There were no issues with the luer adapter, and no other defects or damages were observed on the product at the time of the event.There was nothing unusual observed on the device prior to use.Flushing was done, and the catheter itself was fine.No other products were utilized with the device.The reported product was not replaced.Patient was fine, and there were no consequences due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during the operation, when the guidewire from the kit was introduced into a temporary catheter, the guidewire unraveled upon removal.It was also stated that it uncoiled inside the body.There was not any resistance observed when inserting the guidewire, and there was no tool used when trying to remove it.The guidewire was removed slowly, with no excessive force, to avoid breakage.There were no issues with the luer adapter, and no other defects or damages were observed on the product at the time of the event.There was nothing unusual observed on the device prior to use.Flushing was done, and the catheter itself was fine.No other products were utilized with the device.Patient was fine, and there were no consequences due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that one guidewire that was almost entirely frayed and unraveled.It was reported that the guide wire was frayed.The reported issue was confirmed.The most likely cause could not be established from the information available.This issue can occur when the guidewire became frayed during the operation, it's possible that there was obstruction by biological contamination, such as dried blood.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21662652
• Report Number: 1282497-2025-00179
• Device Sequence Number: 8431533
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888145039P
• Device Catalogue Number: 8888145039P
• Device Lot Number: 241080017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 03/26/2025; 07/02/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 03/26/2025; 03/27/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown