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

Model Number	8888145252
Medical Device Problem Codes	Difficult to Remove (1528); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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, during the procedure, when the guidewire passed from the venous line, the hcp (healthcare professional) noticed that there was some blockage in the venous line.They found that the line was blocked and guidewire did not pass from the catheter line.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior to product placement.There no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, 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 passed from the venous line, the hcp (healthcare professional) noticed that there was some blockage in the venous line.They found that the line was blocked and the guidewire did not pass through the catheter line.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.The insertion site was treated prior to product placement.There was nothing unusual observed on the device prior to use.Betadine was used to treat the insertion site.Flushing was done with a normal result.It was necessary to remove the guide wire and catheter from the patient simultaneously due to the alleged defect.There was no excessive force used to pull/take out the guide wire.There was no blood loss, and a blood transfusion was not required.The implant procedure was completed.The issue was resolved by replacing the catheter with another chronic carbonate catheter.There was no intervention required due to the event.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted some form of plastic warping within the tubing of the venous extension line.A guide wire could not be passed through the venous line as this warping prevented any flow or travel.After forwarding the device to engineering for additional analysis, it was revealed that the root cause of the observed condition is a supplier issue.A retraining event and quality alert have been implemented to prevent this issue from reoccurring.It was reported that the device was occluded, and the guide wire was unable to be withdrawn.The reported issues were confirmed.The most likely cause was determined to be manufacturing related.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, 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: 19571044
• Report Number: 1282497-2024-00174
• Device Sequence Number: 18274087
• Product Code: MSD
• UDI-Device Identifier: 10884521014244
• UDI-Public: 10884521014244
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111372
• 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
• Report Date (Section B): 02/26/2025

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: 8888145252
• Device Catalogue Number: 8888145252
• Device Lot Number: 2318600163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 02/19/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/29/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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 Sex: Unknown