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

Model Number	8888135133
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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, during the ultrasound-guided vessel canalization procedure, the guidewire met resistance and became stuck at the exit through the puncture needle, and as it failed to move or exit, the clinician manually removed both the guidewire and the needle.The guide wire frayed after needle removal but before the catheter was inserted, though it did not break into pieces.The puncture needle did not have any visible damage or dimension issues.The catheter was correctly flushed before use.The puncture needle used belonged to the catheter kit provided by the company.No cleaning agent was used on the device.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.No tools were used to remove the guide wire.No excessive force was applied to the product.The guide wire came from the reported kit.Nothing unusual was observed on the device prior to use.No other defects/damages were found on the product.The clinician ordered a new catheter kit.The issue was addressed by re placing it with a new guide wire from a new catheter kit, which did not cause any inconvenience, and it advanced.The same guide wire and the new catheter from another company were then used on the same day, and the procedure was completed.There was no blood loss.There was no need for a blood transfusion, and no medical intervention or treatment was required as a result of the event.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter during the ultrasound-guided vessel canalization procedure, the guide was frayed, but it did not break into pieces.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.No tools were used to remove the guide wire.No excessive force was applied to the product.The guide wire came from the reported kit.Nothing unusual was observed on the device prior to use.No other defects/damages were found on the product.They replaced it with a guidewire from a central catheter to address the issue.There was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: b5, e1(first name, last name and phone number), e4(email), g2, g3, h3, h6 (fdp, ime, imf, rfr and fdd were updated).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 ultrasound-guided vessel canalization procedure, the guide was frayed, but it did not break into pieces.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.No tools were used to remove the guide wire.No excessive force was applied to the product.The guide wire came from the reported kit.Nothing unusual was observed on the device prior to use.No other defects/damages were found on the product.The clinician removed the guide wire along with the needle because the guide wire did not move or exit the needle and ordered a new catheter kit.The issue was addressed by replacing it with a new guide wire, which did not cause any inconvenience, and it advanced.There was no reported patient injury.
Additional Manufacturer Narrative
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 that the guidewire was visibly uncoiled and frayed.No other abnormalities were observed with the device.It was reported that the guidewire could not be withdrawn and was frayed.The reported issues were confirmed.The most likely cause could not be established from the information available.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.
Additional Manufacturer Narrative
Additional information: b5, 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.
Event or Problem Description
According to the reporter, during the ultrasound-guided vessel canalization procedure, the guidewire met resistance and became stuck at the exit through the puncture needle, and as it failed to move or exit, the clinician manually removed both the guidewire and the needle.The guide wire frayed after needle removal but before the catheter was inserted, though it did not break into pieces.The puncture needle did not have any visible damage or dimension issues.The catheter was correctly flushed before use.The puncture needle used belonged to the catheter kit provided by the company.No cleaning agent was used on the device.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.No tools were used to remove the guide wire.No excessive force was applied to the product.The guide wire came from the reported kit.Nothing unusual was observed on the device prior to use.No other defects/damages were found on the product.All the kit accessories were utilized to advance the high-flow catheter to the patient.The clinician ordered a new catheter kit.The issue was addressed by replacing it with a new guide wire from a new catheter kit, which did not cause any inconvenience, and it advanced.The same guide wire and the new catheter from another company were then used on the same day, and the procedure was completed.There was no blood loss.There was no need for a blood transfusion, and no medical intervention or treatment was required as a result of the event.There was no reported patient injury.

• 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: 21503199
• Report Number: 1282497-2025-00104
• Device Sequence Number: 4591216
• Product Code: MPB
• UDI-Device Identifier: 10884521006256
• UDI-Public: 10884521006256
• 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,Followup,Followup
• Report Date (Section B): 06/03/2025

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: 2324000164
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 03/20/2025; 04/11/2025; 06/02/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/11/2025; 03/25/2025; 04/11/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG