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

Model Number	8888135133
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: d4(unique identifier (udi) #) additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted a guidewire stuck within a puncture needle, and no visual abnormalities were observed with the device. it was reported that the guide wire was unable to be withdrawn.The reported issue was confirmed.The most likely cause could not be established from the information available.This issue can occur due to biological contamination, such as dried blood, within the needle.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.
Event or Problem Description
According to the reporter, during guidewire insertion through the needle (intraoperative), the guidewire incident occurred.No other guidewire was used, and the clinician had to remove the guidewire along with the puncture needle and use a new catheter.No other products in the kit were used.The puncture needle did not present any visible damage or dimension issues.The catheter was correctly flushed prior to use, and the puncture needle belonged to the catheter kit provided by the company.No cleaning agents were used, and there was no blood loss.No medical intervention or treatment was needed.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: b3, b5, d4(expiration date, lot #), g3, h4, h6.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 the procedure, when the guidewire was inserted through the needle (intraoperative), the guidewire became stuck in the needle and could not be removed independently.No tools were used to remove the guide, and no excessive force was applied.The guide came from the notified kit.There was nothing unusual observed in the device before use.No other defects or damages were found in the product.No other products in the kit were used.The puncture needle did not present any visible damage or dimension issues.The catheter was correctly flushed prior to use, and the puncture needle belonged to the catheter kit provided by the company.No cleaning agents were used.No other guidewire was used, and the clinician had to remove the guidewire along with the puncture needle.A new catheter of the same brand and reference was used to complete the procedure successfully on the same day.There was no blood loss.An x-ray was not taken after the procedure.No medical intervention or treatment was needed.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.

• Brand Name: MAHURKAR
• Common Device Name: 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: 21687454
• Report Number: 1282497-2025-00190
• Device Sequence Number: 8850127
• Product Code: MPB
• UDI-Device Identifier: 10884521006256
• UDI-Public: (01)10884521006256(17)290215(10)2324000167
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K192302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 8888135133
• Device Catalogue Number: 8888135133
• Device Lot Number: 2324000167
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 07/09/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/11/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2024
• 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: 58 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG