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

Model Number 8888223216

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

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 Description

According to the reporter, during the catheter placement procedure, the catheter was inserted along the guide wire, but the catheter stopped advancing near the catheter "u" shaft because the guide wire could not be inserted midway through the catheter (u shaft region), so the entire guide wire was pulled out from the patient.It was confirmed that the catheter and the guidewire were removed together manually.The insertion procedure was performed again using the same product from the same lot and product id at the same day of the event, and it seems that placement was possible without any problems.The procedure was continued and completed after replacing the defective device with a new product.When the guidewire where the first incident occurred was checked, it was found to be deformed (bent and kink).The guidewire used was the one included in the kit.There was no leak and there was no luer adapter issue.Flushing was done with no problem.There were no other products being utilized with the device.There was no excessive force used on insertion and withdrawal of the guide wire.There was no blood transfusion required.There was no intervention/medical treatment re quired as the result of the event.There was no reported patient injury.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-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: 19145126
• MDR Text Key: 341128296
• Report Number: 1282497-2024-00056
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125926
• UDI-Public: 10884521125926
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 8888223216
• Device Catalogue Number: 8888223216
• Device Lot Number: 2230300065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1