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

Model Number	8888145015P
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 8888145044c, 8888145044c palindrome h 23/40kit vt, (lot#2326900119); 8888145015p, 8888145015p 23/40 palindrome p kit, (lot#2335200422), 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, an alert from the pharmacy for indoor use on overconsumption of fibrinolytic (actilysis) since the beginning of january.In service call, it was stated that presence of an increase in blocked catheters (placed in another establishment).The insertion site was treated with prior to product placement.It was also stated that there were patients symptoms or complications associated with the event such as delay in patient care or extension of hospitalization, disruption of the operation of the service or inter-service relations.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, an alert from the pharmacy for indoor use on overconsumption of fibrinolytic (actilysis) has been in place since the beginning of january.In the service call, it was stated that there was an increase in blocked catheters (placed in another establishment).There was nothing unusual observed on the device prior to use.The catheter has been placed for almost three months.There was no leak, and tego was not utilized.There was no luer adapter issue.There was excessive force use on the device.The customer did not try to reverse the lines.The occlusion was due to thrombosis.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.Actilyse was the remedial action performed.The treatment proceeded and was completed after the remedial action was done.There was no intervention/treatment required as a result of the event.Blood transfusion was not required due to the event.The patient had not been hospitalized, and 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, an alert from the pharmacy for indoor use on overconsumption of fibrinolytic (actilysis) has been in place since the beginning of january.In the service call, it was stated that there was an increase in blocked catheters (placed in another establishment).There was nothing unusual observed on the device prior to use.The catheter has been placed for almost three months.There was no leak, and tego was not utilized.There was no luer adapter issue.Chlorhexidine alcoolique was the cleaning agent used in the device.There was excessive force use on the device.The customer did not try to reverse the lines.The occlusion was due to thrombosis.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.Actilyse was the remedial action performed.The treatment proceeded and was completed after the remedial action was done.There was no intervention/treatment required as a result of the event.Blood transfusion was not required due to the event.The patient had not been hospitalized, and there was no reported patient injury.
Event or Problem Description
According to the reporter, an alert from the pharmacy for indoor use on overconsumption of fibrinolytic (actilysis) has been in place since the beginning of january.In the service call, it was stated that the catheter was blocked.There was nothing unusual observed on the device prior to use.The catheter has been placed for almost three months.There was no leak, and tego was not utilized.There was no luer adapter issue.Chlorhexidine alcoolique was the cleaning agent used in the device.There was no excessive force use on the device.The customer did not try to reverse the lines.The occlusion was due to thrombosis.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.Actilyse was the remedial action performed.The treatment proceeded and was completed after the remedial action was done.There was no intervention/treatment required as a result of the event.Blood transfusion was not required due to the event.The patient had not been hospitalized, and there was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g3, h6 (fdp, ime, imf) 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.

• 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: 21313844
• Report Number: 1282497-2025-00057
• Device Sequence Number: 8169428
• Product Code: MSD
• UDI-Device Identifier: 10884521157989
• UDI-Public: 10884521157989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 2335200422
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 02/21/2025; 03/27/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/11/2025; 02/26/2025; 03/31/2025
• Date Device Manufactured: 01/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 72 KG