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

Model Number	8888145016
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Hypervolemia (2664); Swelling/ Edema (4577); Hyperkalemia (4824)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during hemodialysis, the catheter did not provide adequate blood flow in the arterial lumen and dialysate with efficiency.There was lack of blood return indicating difficulty with flow.The catheter was not difficult to flush with the syringe, and blood was returned prior to flushing.Flushing was performed, and blood return was achieved through the routes.Chlorhexidine was being used on the tips before the lines were installed.There was no leak.Tego was not used.Nothing unusual was observed on the device prior to use.No other defects/damages were found in the product.No other products being used with the device.The patient did not use heparin during the dialysis session due to a history of chronic subdural hematoma.The intraluminal heparin was specifically used during the interdialytic period.The patient was on aspirin (asa) and clopidogrel for dual antiplatelet therapy, after recent myocardial infarction (ami).The reverse flow was not successful as movement of blood in the venous was slower.After a shorter session time of dialysis, the patient presented with hyperkalemia and acute edema.The customer exchanged the catheter with the same lot.There was blood loss on the catheter ostium.Blood transfusion was not required.The patient had extra session as medical intervention/treatment required as a result of the event.Additionally, the patient experienced recurrent surgical procedures, admission, and hypervolemia as complications related to the event.
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 hemodialysis, the catheter did not provide adequate blood flow in the arterial lumen and dialysate with efficiency.There was a lack of blood return, indicating difficulty with flow.The catheter was not difficult to flush with the syringe, and blood was returned prior to flushing.Flushing was performed, and blood return was achieved through the routes.Chlorhexidine had been used on the tips before the lines were installed.Tego was not used.Nothing unusual had been observed on the device prior to use.No other defects or damages were found in the product.No other products were being used with the device.The duration of catheter use was 23 days.The patient had not used heparin during the dialysis session, though intraluminal heparin had been used in the interdialytic period.The patient had also been on dual antiplatelet therapy with aspirin (aas) and clopidogrel.The reverse flow was not successful as the movement of blood in the venous was slower.After a shorter dialysis session, the patient presented with hyperkalemia and acute edema.The customer had exchanged the catheter with the same lot on (b)(6) 2025, and treatment was completed with the replacement catheter, though the session duration was reduced.Blood loss at the catheter ostium was confirmed, but the exact volume was not quantified, with no leakage observed at the catheter¿s structural integrity, meaning the loss was localized at the ostium.The blood loss was related to the patient¿s use of intraluminal heparin and dual antiplatelet therapy.Blood transfusion was not required.The patient had an extra session as medical intervention/treatment was required as a result of the event.Additionally, the patient had experienced recurrent surgical procedures, which included the procedures of catheter replacement, admission, and hypervolemia as complications related to the event.Post-event medications were not reported.The patient¿s status, including hypervolemia and hyperkalemia, had been controlled after hospitalization.
Additional Manufacturer Narrative
Additional information: b5, e1 (region), g3 correction: a1, e1 (postal code - removed).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.
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 hemodialysis, the catheter did not provide adequate blood flow in the arterial lumen and dialysate with efficiency.There was a lack of blood return, indicating difficulty with flow.The catheter was not difficult to flush with the syringe, and blood was returned prior to flushing.Flushing was performed, and blood return was achieved through the routes.Chlorhexidine had been used on the tips before the lines were installed.Tego was not used.Nothing unusual had been observed on the device prior to use.No other defects or damages were found in the product.No other products were being used with the device.The duration of catheter use was 23 days.The patient had not used heparin during the dialysis session due to a history of chronic subdural hematoma, though intraluminal heparin had been used in the interdialytic period.The patient had also been on dual antiplatelet therapy with aspirin (aas) and clopidogrel after a recent myocardial infarction.The reverse flow was not successful as the movement of blood in the venous was slower.After a shorter dialysis session, the patient presented with hyperkalemia and acute edema.The customer had exchanged the catheter with the same lot on (b)(6) 2025, and treatment was completed with the replacement catheter, though the session duration was reduced.Minor blood loss at the catheter ostium was confirmed, but the exact volume was not quantified, with no leakage observed at the catheter¿s structural integrity, meaning the loss was localized at the ostium.The blood loss was related to the patient¿s use of intraluminal heparin and dual antiplatelet therapy.Blood transfusion was not required.The patient had an extra session as medical intervention/treatment was required as a result of the event.Additionally, the patient had experienced recurrent surgical procedures, which included the procedures of catheter replacement, admission, and hypervolemia as complications related to the event.Post-event medications were not reported.The patient¿s status, including hypervolemia and hyperkalemia, had been controlled after hospitalization.
Additional Manufacturer Narrative
H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted the catheter in use, with apparent flow issues.There appeared to be no physical abnormalities with the device.It was reported that there was an insufficient flow issue.The reported issue was 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 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: 21505971
• Report Number: 1282497-2025-00112
• Device Sequence Number: 12756121
• Product Code: MSD
• UDI-Device Identifier: 10884521013179
• UDI-Public: 10884521013179
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/17/2025

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: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 2330300115
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 05/27/2025; 06/16/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/18/2025; 05/30/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 70 KG