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

Model Number	8888145015P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
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, during the operation, the catheter was checked, and trachoma was found on the arterial end of the extension tube.There was a leak at the bifurcate, and there was no luer adapter issue.The insertion site was not treated prior to product placement, and tego was not utilized.No cleaning agent was used on the device.The catheter was not repaired and was replaced.The operation was completed.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: a2, a3a, b5, g3, h6(fdp, ime and imf codes were updated).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, before the operation, the catheter was checked, and trachoma was found on the arterial end of the extension tube.There was no luer adapter issue.Flushing was performed, and leakage occurred at the bifurcation.No other defects or damages were found on the product where the leak was observed.Nothing else unusual was observed on the device prior to use.No other products were utilized with the device.No excessive force was applied.The insertion site was not treated prior to product placement, and tego was not utilized.No cleaning agent was used on the device.The catheter was not repaired, and as a remedial action, it was replaced with another one with the same product id on the same day as the event.The operation was completed.There was no blood loss, and blood transfusion was not performed.No medical intervention was required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3.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, before the operation, the catheter was checked, and trachoma (sand hole) was found on the arterial end of the extension tube near the luer adapter.There was a leak at the extension tube.There was no luer adapter issue.There was no leak at the fork.Flushing was performed prior to use, and leakage occurred.No other defects or damages were found on the product where the leak was observed.Nothing else unusual was observed on the device prior to use.No other products were utilized with the device.No excessive force was applied on the device.The insertion site was not treated prior to product placement, and tego was not utilized.No cleaning agent was used on the device.The catheter was not repaired, and as a remedial action, it was replaced with another one with the same product id on the same day as the event.The operation was completed.There was no blood loss, and blood transfusion was not performed.No medical intervention was required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3.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, before the operation, the catheter was checked, and trachoma (sand hole) was found on the arterial end of the extension tube near the luer adapter.Flushing was performed prior to use, and leakage was observed at the arterial end of the extension tube.There was no luer adapter issue, and no leak at the bifurcation.No other defects or damages were found on the product where the leak was observed.Nothing else unusual was observed on the device prior to use.No other products were used with the device.No excessive force was applied.The insertion site was not treated prior to product placement, and tego was not used.No cleaning agent was used.The catheter was not repaired.As a remedial action, it was replaced with another one with the same product id on the same day as the event.The operation was completed.There was no blood loss, and no blood transfusion was performed.No medical intervention was required 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 catheter, with a visible pin-hole leak.There appeared to be no other abnormalities with the device.It was reported that there was a leak on the extension tube.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue can occur because the catheter came into contact with a sharp instrument during use.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: 21708173
• Report Number: 1282497-2025-00192
• Device Sequence Number: 18630119
• 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
• 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,Followup
• Report Date (Section B): 05/06/2025

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: 2305300167
• 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: 03/23/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 04/08/2025; 04/17/2025; 05/02/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/02/2025; 04/11/2025; 04/22/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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: 65 YR
• Patient Sex: Female