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	Insufficient Information (4580)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the installation of the right double lumen catheter, when the doctor was performing the procedure and canneling the device, the doctor tried to remove the guide, felt difficulty, tracled, and removed the guide completely.It was observed to be stretched, losing its shape, so they performed the procedure again.With a new device with the same lot, this time in the left jugular area.When performing the removal maneuver of the new guide, it was observed that it was frayed like the previous attempt.The catheter was not repaired.There was no leak.There was no problem with the luer adapter.There was no reported patient outcome.
Additional Manufacturer Narrative
D10 concomitant product: 8888135191, 8888135191 13.5frx19.5cm mahka q+ sekit (lot#2327000124).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
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 installation of the right double lumen catheter, when the doctor was performing the procedure and canneling the device, the doctor tried to remove the guide and the catheter one time, felt difficulty, tracled, and removed theguide completely.It was observed to be stretched, losing its shape (frayed), so they performed the procedure again.With a new device with the same lot, this time in the left jugular area.The guide wire was inserted at 10 cm, and a stop was felt, when performing the removal maneuver of the new guide, it was observed that it was frayed like the previous attempt.An excessive force was used to remove the guide wire.All pieces were accounted for.There was nothing unusual observed on the device prior to use.There were no other visible defects/damages found on the product.Clorexhidina 2% was used to treat the insertion site prior to product placement.There was no damage/defect to the catheter itself.The catheter was not repaired.There was no leak.There was no problem with the luer adapter.Tego was not utilized.The sheath/catheter that came with the kit was the one used.There was no occlusion.Flushing was done prior to use with no problem.Suero fisiologico was the cleaning agent used on the device.There were no other products being utilized with the device.There was 10 ml of blood loss, and a blood transfusion was not required at the time of the event.The blood was not returned safely to the patient.Change the catheter with the other batch was the remedial and intervention required as a result of the vent.The device was used successfully.The treatment proceeded and was completed.An x-ray was done during the post-procedure.There was no 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: 19957983
• Report Number: 1282497-2024-00310
• Device Sequence Number: 8801353
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2327000124
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/11/2024
• Supplement Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 10/01/2023
• 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: 73 YR
• Patient Sex: Male