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

Model Number	8888145015P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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, the patient underwent long-term chronic catheter placement for renal dialysis in the endocrine and nephrology department on (b)(6) 2025, followed by routine hemodialysis postoperatively.On the day of the event, bleeding was observed at the junction between the dialysis catheter and the long-term catheter interface during dialysis.Investigation suggested that the mismatch in material compatibility between the long-term catheter and the hemodialysis circuit components led to damage at the catheter connection.After replacing the long-term catheter connector, bleeding did not recur.Additionally, an arteriovenous fistula was created to ensure vascular access for ongoing dialysis.The catheter was not repaired.There was a leak and crack at the venous(blue) adapter.Tego was not utilized.Nothing unusual observe on the device prior to use.Flushing was done with normal result.Besides the reported issue, there were no any other visible defects/damages found on the product at the time of the event.The insertion site was not treated prior to product placement.No excessive force use on the device.As a remedial action and intervention, the connector was replaced and the procedure was able to complete.The cleaning agent(s) are allowed to dry thoroughly prior to applying ointment(s) to the area.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3 correction: b5.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, the patient underwent long-term chronic catheter placement for renal dialysis in the endocrine and nephrology department on (b)(6) 2025, followed by routine hemodialysis postoperatively.On the day of the event, bleeding was observed at the junction between the dialysis catheter and the long-term catheter interface during dialysis.Investigation suggested that the mismatch in material compatibility between the long-term catheter and the hemodialysis circuit components led to damage at the catheter connection.After replacing the long-term catheter connector, bleeding did not recur.Additionally, an arteriovenous fistula was created to ensure vascular access for ongoing dialysis.The catheter was not repaired.There was a leak and crack at the venous(blue) adapter.Tego was not utilized.Nothing unusual was observed on the device prior to use.Flushing was done with normal results.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The insertion site was not treated prior to product placement.No excessive force was used on the device.As a remedial action and intervention, the connector was replaced, and the procedure was able to be completed.The cleaning agent(s) are allowed to dry thoroughly prior to applying ointment(s) to the area.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
Event or Problem Description
According to the reporter, the patient underwent long-term chronic catheter placement for renal dialysis in the endocrine and nephrology department on february 5, 2025, followed by routine hemodialysis postoperatively.On the day of the event, bleeding was observed at the junction between the dialysis catheter and the long-term catheter interface during dialysis.Investigation suggested that the mismatch in material compatibility between the long-term catheter and the hemodialysis circuit components led to damage at the catheter connection.The catheter was not repaired.There was a leak and crack at the venous (blue) adapter.Tego was not utilized.Nothing unusual was observed on the device prior to use.Flushing was done with normal results.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The insertion site was not treated prior to product placement.No excessive force was used on the device.The cleaning agent(s) were allowed to dry thoroughly prior to applying ointment(s) to the area.After replacing the long-term catheter connector, bleeding did not recur.Additionally, an arteriovenous fistula was created to ensure vascular access for ongoing dialysis.There was no blood loss, and blood transfusion was not required.As a remedial action and intervention, the connector was replaced, and the procedure was able to be completed.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3 correction: b5 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: g3.Correction: b5.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, the patient underwent long-term chronic catheter placement for renal dialysis in the endocrine and nephrology department on (b)(6) 2025, followed by routine hemodialysis postoperatively.On the day of the event, bleeding was observed at the junction between the dialysis catheter and the long-term catheter interface during dialysis.There was a leak and crack at the venous (blue) adapter.Investigation suggested that the mismatch in material compatibility between the long-term catheter and the hemodialysis circuit components led to damage at the catheter connection.Tego was not utilized.Nothing unusual was observed on the device prior to use.Flushing was done with normal results.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.The insertion site was not treated prior to product placement.No excessive force was used on the device.The cleaning agent(s) were allowed to dry thoroughly prior to applying ointment(s) to the area.The catheter was not repaired.As a remedial action and intervention, the connector was replaced, and the procedure was able to be completed.After replacing the long-term catheter connector, bleeding did not recur.Additionally, an arteriovenous fistula was created to ens ure vascular access for ongoing dialysis.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• 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: 22214214
• Report Number: 1282497-2025-00408
• Device Sequence Number: 18182171
• Product Code: MSD
• UDI-Device Identifier: 10884521157989
• UDI-Public: 10884521157989
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 07/02/2025

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: 8888145015P
• Device Catalogue Number: 8888145015P
• Device Lot Number: 2329000418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 06/25/2025; 07/01/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/17/2025; 06/25/2025; 07/02/2025
• Date Device Manufactured: 10/29/2023
• 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 Age: 56 YR
• Patient Sex: Unknown