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

Model Number	8888145039P
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Serious 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, when placing the reported product, the guidewire became stuck halfway through, but when they tried to remove it anyway, the tip of the guidewire broke off halfway through and remained subcutaneously in the internal jugular vein.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.There was no excessive force used on the device.Flushing was done prior to use, and there was no problem.There was no leak.There was no cleaning agent used on the device.Tego was not utilized.There was no connector issue.The insertion site was not handled prior to product placement.The guidewire provided with the kit was being used.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, they had to surgically incise it and remove the broken guidewire.As a result, the tip of the guidewire broke off and was damaged and deformed.All of the guidewire, including the tip that broke off, was successfully removed during the procedure.However, the guidewire was not replaced, and the procedure was not completed.There was an unspecified blood loss, and a blood transfusion was not required.
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 placing the reported product, the guidewire became stuck halfway through, but when they tried to remove it anyway, the tip of the guidewire broke off halfway through and remained subcutaneously in the internal jugular vein.Nothing unusual was observed on the device prior to use.There were no other products being utilized with the device.There was no excessive force used on the device.Flushing was done prior to use, and there was no problem.There was no leak.There was no cleaning agent used on the device.Tego was not utilized.There was no connector issue.The insertion site was not handled prior to product placement.The guidewire provided with the kit was being used.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, they had to surgically incise it and remove the broken guidewire.As a result, the tip of the guidewire broke off and was damaged and deformed.All of the guidewire, including the tip that broke off, was successfully removed during the procedure.An x-ray was done during the post-procedure.However, the guidewire was not replaced, and the procedure was not completed.There was an unspecified blood loss, and a blood transfusion was not required.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 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
Additional information: d9, g3, h3, h6 h3 evaluation summary: mozarc medical conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one catheter, two dilators, and one guidewire that was visibly uncoiled, frayed, and broken.Upon first inspection, a standard guidewire was inserted into each extension line of the catheter without difficulty.No other abnormalities were noted with the returned device.It was reported that the guidewire broke apart and was unable to be withdrawn.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all mozarc medical quality specifications.A secondary review of the device history records found no potentially contributing factors.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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22864341
• Report Number: 1282497-2025-00560
• Device Sequence Number: 15787425
• Product Code: MSD
• UDI-Device Identifier: 10884521158023
• UDI-Public: 10884521158023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888145039P
• Device Catalogue Number: 8888145039P
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 02/16/2026; 02/20/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/26/2025; 02/16/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown