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

Model Number	8888145002
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	12/02/2024
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.
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.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 catheter replacement, the patient's arteriovenous suction flow was poor and easily stuck to the blood vessel wall, resulting in insufficient hemodialysis flow.The current usage showed reversing was not possible, but the forward flow was not good.The catheter flow difference and the catheter adjustment situation have been reflected in the course of disease and dialysis records.The catheter depth was at the inner port at the th9 level.The dialysis machine repeatedly alarmed, making it difficult to perform hemodialysis.The incidence of catheter flow difference was as high as 71.43%.There was no reported patient outcome.   .
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (codes).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 catheter replacement, the patient's arteriovenous suction flow was poor and easily stuck to the blood vessel wall, resulting in insufficient hemodialysis flow.The customer noticed that there was insufficient flow during the first use of the catheter after catheterization.The current usage showed that reversing was not possible, but the forward flow was not good.The catheter flow difference and the catheter adjustment situation have been reflected in the course of the disease and dialysis records.The dr chest radiograph catheter was at the inner port at the th9 level.The dialysis machine repeatedly alarmed, making it difficult to perform hemodialysis.The incidence of catheter flow difference was as high as 71.43%.Nothing unusual was observed on the device prior to use, and no other damage was found on the product.Flushing was performed with normal results.No other products were utilized with the device, and no excessive force was used.No cleaning agent was used on the device.There was no problem with the luer adapter; there was no leak, and the catheter was not repaired and was used reluctantly.Tego was not used, and the insertion site was not treated prior to product placement.The line was not difficult to flush with the syringe, and there was no blood return prior to syringe flushing.Heparin was used for anticoagulation.The reverse flow was worse.This was not the infusion line.As a remedial action, the catheter had to be adjusted, and the procedure was completed.Due to the event, the patient had low-flow dialysis.There was no blood loss, and no blood transfusion was performed.There was no reported patient outcome.
Event or Problem Description
According to the reporter, the department began using the semi-permanent hemodialysis catheter¿central venous catheter kit for hemodialysis.After catheter replacement, the patient's arteriovenous suction flow was poor and easily stuck to the blood vessel wall, resulting in insufficient hemodialysis flow.The customer noticed that there was insufficient flow during the first use of the catheter after catheterization.The current usage showed that reversing was not possible, but the forward flow was not good.The catheter flow difference and the catheter adjustment situation have been reflected in the course of the disease and dialysis records.The dr chest radiograph catheter was at the inner port at the th9 level.The dialysis machine repeatedly alarmed, making it difficult to perform hemodialysis.The incidence of catheter flow difference was as high as 71.43%.Nothing unusual was observed on the device prior to use, and no other damage was found on the product.Flushing was performed with normal results.No other products were utilized with the device, and no excessive force was used.No cleaning agent was used on the device.There was no problem with the luer adapter; there was no leak, and the catheter was not repaired and was used reluctantly.Tego was not used, and the insertion site was not treated prior to product placement.The line was not difficult to flush with the syringe, and there was no blood return prior to syringe flushing.Heparin was used for anticoagulation.The reverse flow was worse.This was not the infusion line.As a remedial action, the catheter had to be adjusted, and the procedure was completed.Due to the event, the patient had low-flow dialysis.There was no blood loss, and no blood transfusion was performed.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, 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: 21139428
• Report Number: 1282497-2025-00028
• Device Sequence Number: 12469772
• Product Code: MSD
• UDI-Device Identifier: 10884521014145
• UDI-Public: 10884521014145
• 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,Foreign,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: 8888145002
• Device Catalogue Number: 8888145002
• Device Lot Number: 2324100119
• 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; 01/04/2025; 02/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/13/2025; 01/30/2025; 02/10/2025
• Date Device Manufactured: 11/08/2023
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 52 KG