MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	8813793009
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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, on (b)(6),2024, the patient was admitted to the hospital due to dyspnea for more than 3 hours.After admission, the patient was mainly diagnosed with acute heart failure, chronic kidney disease stage 5, etc., so temporary hemodialysis catheter placement in the right femoral vein was performed under local anesthesia at the bedside in the nephrology ward.After the operation, bedside hemodialysis treatment was performed, and due to worsening heart failure and acute respiratory failure, the patient was transferred to the department of critical care medicine on the same day.The patient was transferred to the icu (intensive care unit) for crrt (continuous renal replacement therapy) treatment to remove excess toxins and water in the body and maintain the stability of the internal environment.On the morning of (b)(6) 2024, the patient's hemodialysis machine alarmed that the venous pressure was high and the hemodialysis process was not smooth, and the patient got off the machine.After the nurse checked, a rupture was found at the venous end interface (blue venous extension tube) of the temporary hemodialysis catheter in the right f emoral vein, and there was blood leakage.The catheter had been in place for two days.The leak was located in the y-connection tip with splitting of the arterial extension.The insertion site was treated prior to product placement (disinfection and local anesthesia).Nothing unusual was observed on the device prior to use.Flushing was done with no abnormalities found.Cracks were the only defect that was found on the product where the leak was observed.No other products were being utilized with the device.No excessive force was used on the device.Chlorhexidine was the cleaning agent used on the device and was typically used to clean the adapters.Cleaning agents were allowed to dry thoroughly prior to applying ointments.The clamps were not moved to a new location after each treatment.The catheter and accessories were replaced immediately to avoid affecting the patient's treatment and ensure the patient's safety.Replaced with new tube was the medical intervention/treatment done to the patient as a result of the event.The treatment was completed.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.
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, on (b)(6) 2024, the patient was admitted to the hospital due to dyspnea for more than 3 hours.After admission, the patient was mainly diagnosed with acute heart failure, chronic kidney disease stage 5, etc., so temporary hemodialysis catheter placement in the right femoral vein was performed under local anesthesia at the bedside in the nephrology ward.After the operation, bedside hemodialysis treatment was performed, and due to worsening heart failure and acute respiratory failure, the patient was transferred to the department of critical care medicine on the same day.The patient was transferred to the icu (intensive care unit) for crrt (continuous renal replacement therapy) treatment to remove excess toxins and water in the body and maintain the stability of the internal environment.On the morning of september 30, 2024, the patient's hemodialysis machine alarmed that the venous pressure was high and the hemodialysis process was not smooth, and the patient got off the machine.After the nurse checked, a rupture was found at the venous end interface (blue venous extension tube) of the temporary hemodialysis catheter in the right f emoral vein, and there was blood leakage.The catheter had been in place for two days.The leak was located in the y-connection tip with splitting of the arterial extension.The insertion site was treated prior to product placement (disinfection and local anesthesia).Nothing unusual was observed on the device prior to use.Tego was not utilized.There was no luer adapter issue.Flushing was done with no abnormalities found.Cracks were the only defect that was found on the product where the leak was observed.No other products were being utilized with the device.No excessive force was used on the device.Chlorhexidine was the cleaning agent used on the device and was typically used to clean the adapters.Cleaning agents were allowed to dry thoroughly prior to applying ointments.The clamps were not moved to a new location after each treatment.The catheter and accessories were replaced immediately to avoid affecting the patient's treatment and ensure the patient's safety.Replaced with new tube was the medical intervention/treatment do ne to the patient as a result of the event.The treatment was completed.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 20669033
• Report Number: 1282497-2024-20015
• Device Sequence Number: 7304757
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 2218100106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 07/29/2022
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 58 KG