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

Model Number	8888145017
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the operation, when the surgeon was operating the tunnel needle, the plastic accessories of the tunnel needle were broken, and the operation could not be completed normally.There was a leak.The catheter was not repaired, and no tego was utilized.There was no issue with the luer adapter.The insertion site was not treated prior to product placement.No cleaning agent was used.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 surgeon was operating the tunnel needle and when the clinician was trying to pull it apart as part of the removal process, the plastic accessories of the tunnel needle were broken, and the operation could not be completed normally.There was no leak.The catheter was not repaired, and no tego was utilized, and there was no issue with the luer adapter.The insertion site was not treated prior to product placement.No cleaning agent was used.The tunneler being used was the one included in the kit.Flushing was done prior to use, and the result was normal.No other products were being utilized with the device, and nothing unusual was observed on the device prior to use.There were no other defects or damages found on the product.The kit was replaced as remedial action with a new product on the same day, from a different product id (identifier) and a different lot number.After remedial action, the procedure was completed.There was no blood loss, and no blood transfusion was required.No medical intervention or treatment was required as a result of 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.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that one catheter kit, with all of its components being returned.Upon first inspection, a crack/tear was noted on the plastic sheath of the steel tunneler.It was reported that the tunneler broke apart.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: 21980771
• Report Number: 1282497-2025-00307
• Device Sequence Number: 9095277
• Product Code: MSD
• UDI-Device Identifier: 10884521013193
• UDI-Public: 10884521013193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 8888145017
• Device Catalogue Number: 8888145017
• Device Lot Number: 2320000221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 07/02/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/12/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2023
• 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: Male