MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR ELITE; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL

Model Number	8888233216
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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, when preparing for the surgery, an interview with the physician, who was in charge of the department of nephrology and hypertension, stated that the problem in this case was that the center lumen was clogged.They tried to pass saline through the center lumen but they were unable to get it through.Furthermore, when they tried to pass the guide wire through, it did not pass.The component involved in the problem was just the catheter.They noticed it before using it on a patient, so they did not use it on a patient, the product was never implanted, and it was responded with another product of the same brand as remedial action.There was no reported patient injury.
Event or Problem Description
According to the reporter, when preparing for the surgery, an interview with the physician, who was in charge of the department of nephrology and hypertension, stated that the problem in this case was that the center lumen was clogged.They tried to pass saline through the center lumen, but they were unable to get it through.Furthermore, when they tried to pass the guide wire through, it did not pass.The component involved in the problem was just the catheter.The guidewire was not frayed, coiled or unraveled.No other visible defects/damages found on the product.No packaging damage.Nothing unusual observed on the device prior to use.No other products being utilized with the reported device.No excessive force used on the reported device.No cleaning agent used.They noticed it before using it on a patient, so they did not use it on a patient, the product was never implanted, and it was responded with an other product of the same brand as remedial action.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.
Event or Problem Description
According to the reporter, when preparing for the surgery, an interview with the physician, who was in charge of the department of nephrology and hypertension, stated that the problem in this case was that the center lumen was clogged.They tried to pass saline through the center lumen, but they were unable to get it through.Furthermore, when they tried to pass the guide wire through, it did not pass.The component involved in the problem was just the catheter.The guidewire was not frayed, coiled or unraveled.No other visible defects/damages found on the product.No packaging damage.Nothing unusual observed on the device prior to use.No other products being utilized with the reported device.No excessive force used on the reported device.No cleaning agent used.They noticed it before using it on a patient, so they did not use it on a patient, the product was never implanted, and it was responded with an other product of the same brand as remedial action.The procedure was completed using another product from the same brand.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.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no abnormalities, however, when the device was flushed, an obstruction was noted.Functional testing found that the tip of the cannula was cut open to reveal that the tip was completely occluded.It was reported that the device was occluded.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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 ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL
• 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: 19154162
• Report Number: 1282497-2024-00057
• Device Sequence Number: 7960722
• Product Code: NIE
• UDI-Device Identifier: 10884521127661
• UDI-Public: 10884521127661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888233216
• Device Catalogue Number: 8888233216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 04/24/2024; 08/06/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/03/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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