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

Model Number	8888135191
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
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 hemodialysis central venous catheter placement, it was found that the guidewire spring was loose, and the hemodialysis central venous catheter was unable to implant.The guidewire was replaced.There was no reported patient injury.
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 hemodialysis central venous catheter placement, when the guidewire was pulled out after the needle was inserted into the patient, it was found that the guidewire spring was loose (unraveled), and the hemodialysis central venous catheter was unable to be implanted.There was no leak and no luer fitting issue.Tego was not utilized.There were no abnormalities on the device other than previous use.In addition to the reported issue, there was no other defect/damage visible on the product at the time of the event.There was no excessive force applied to the device.The cleaning agent used on the device was normal saline.No other product was used prior to the issue.It was stated that it was manually removed while removing the wire and needle.When the guidewire was removed, it was only loosened and not broken.As a remedial action, the guidewire was replaced with an unknown brand and product information.After the issue occurred , the procedure was continued using another product guidewire and needle.The procedure was completed after the remedial action was done.There was no blood loss.The event did not require a blood transfusion.There was no reported patient injury.
Event or Problem Description
According to the reporter, during hemodialysis central venous catheter placement, when the guidewire was pulled out after the needle was inserted into the patient, it was found that the guidewire spring was loose (unraveled), and the hemodialysis central venous catheter was unable to be implanted.There was no leak and no luer fitting issue.Tego was not utilized.There were no abnormalities on the device other than previous use.In addition to the reported issue, there was no other defect/damage visible on the product at the time of the event.There was no excessive force applied to the device.The cleaning agent used on the device was normal saline.No other product was used prior to the issue.It was stated that it was manually (simultaneously) removed while removing the wire and needle from the patient due to the alleged defect.When the guidewire was removed, it was only loosened and not broken.As a remedial action, the guidewire was replaced with an unknown brand and product information.After the issue occurred , the procedure was continued using another product guidewire and needle.The procedure was completed after the remedial action was done.There was no blood loss.The event did not require a blood transfusion.There were no medical intervention/treatment done to the patient as a result of the event.There was no reported patient injury.
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.
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 one guidewire was stuck within a puncture needle.There appeared to be no abnormalities with the device.It was reported that the guidewire was unraveled.The reported issue was 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.

• 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: 21873246
• Report Number: 1282497-2025-00254
• Device Sequence Number: 15383408
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2025

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2226500201
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/19/2025; 07/10/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/22/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• 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: Unknown