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

Model Number	8888145001
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	12/03/2024
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 department began using the semi-permanent hemodialysis catheter-central venous catheter kit for hemodialysis.After the catheter replacement, the patient's arteriovenous suction flow was poor and easily adhered to the blood vessel wall, resulting in insufficient hemodialysis flow.The user noticed the insufficient flow during the first use after catheterization.The catheter had poor reverse flow.It was not the infusion line.The catheter flow difference and the catheter adjustment situation were reflected in the medical history and dialysis records.The catheter depth on the dr chest x-ray was at the tip of the right vertebral margin.The dialysis machine repeatedly alarmed, making it difficult to perform hemodialysis.Nothing unusual was observed on the device prior to use, and no other damage to the product was found.There was no problem with the luer adapter and there was no leak.The catheter was used reluctantly.Tego was not used and the insertion site was not treated prior to product placement.Fl ushing was performed and the line was not difficult to flush with the syringe and the catheter was intact as a result.There was no blood return prior to syringe flushing.No other products were used with the device and no excessive force was used.No cleaning agent was used on the device.Extracorporeal anticoagulation was used for anticoagulation.There was no blood loss and no blood transfusion was performed.The catheter had to be adjusted several times.The incidence of catheter flow difference was 71.43%.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.
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 department began using the semi-permanent hemodialysis catheter-central venous catheter kit for hemodialysis.After the catheter replacement, the patient's arteriovenous suction flow was poor and easily adhered to the blood vessel wall, resulting in insufficient hemodialysis flow.The user noticed the insufficient flow during the first use after catheterization.The catheter had poor reverse flow.It was not the infusion line.The catheter flow difference and the catheter adjustment situation were reflected in the medical history and dialysis records.The catheter depth on the dr chest x-ray was at the tip of the right vertebral margin.The dialysis machine repeatedly alarmed, making it difficult to perform hemodialysis.Nothing unusual was observed on the device prior to use, and no other damage to the product was found.There was no problem with the luer adapter, and there was no leak.The catheter was used reluctantly.Tego was not used, and the insertion site was not treated prior to product placement.Flushing was not performed, and the line was not difficult to flush with the syringe, and the catheter was intact as a result.There was no blood return prior to syringe flushing.No other products were used with the device, and no excessive force was used.No cleaning agent was used on the device.Extracorporeal anticoagulation was used for anticoagulation.As a remedial action, the catheter had to be adjusted several times, and the procedure was completed.The incidence of catheter flow difference was 71.43%.Due to the event of low-flow dialysis, there was a decrease in the dialysis adequacy.There was no blood loss, and no blood transfusion was performed.There was no required medical intervention and treatment due to the event, and the patient was in stable condition.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: e4(email), 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.

• Brand Name: MAHURKAR
• 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: 21138721
• Report Number: 1282497-2025-00026
• Device Sequence Number: 6957634
• Product Code: MSD
• UDI-Device Identifier: 10884521014084
• UDI-Public: 10884521014084
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 8888145001
• Device Catalogue Number: 8888145001
• Device Lot Number: 2330300070
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 01/20/2025; 02/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/13/2025; 01/29/2025; 02/10/2025
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 50 KG