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

Model Number	8888145003
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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, the product's gray element (which they tear when implanting the catheter) ended with a non-return valve that prevented blood outflow (transparent latch).Unfortunately, it did not fulfill its function, so there was an intense outflow of blood through the non-return valve itself at the end of the tunnel or guidewire into which the actual vascular catheter was inserted and below (between the gray, tearable element and the transparent latch).The catheter was not repaired.There was no luer adapter issue.Massive bleeding occurred, and it was necessary to interrupt the procedure.They removed the above-mentioned element and transfused blood into the patient.
Additional Manufacturer Narrative
New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.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, the pull-apart sheath, which was the product's gray element (which they tear when implanting the catheter), ends with a non-return valve that prevents blood outflow (transparent latch).Unfortunately, it did not fulfill its function, so there was an intense outflow of blood through the non-return valve itself at the end of the tunnel or guidewire into which the actual vascular catheter was inserted and below (between the gray, tearable element and the transparent latch).The catheter was not repaired.There was no luer adapter issue.Nothing unusual was observed on the device prior to use.Flushing was done prior to use, and the result was normal.No other products were being utilized with the device.The reported pull-apart sheath was the one included in the kit.The insertion site was treated with betadine prior to product placement.Massive bleeding occurred, and it was necessary to interrupt the procedure.They removed the above-mentioned element.A new product was opened as remedial action performed to address the issue.There was unspecified amount of blood loss.No blood transfusion was administered to the patient.The patient was stable.There was no reported patient injury.

• 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: 19818018
• Report Number: 1282497-2024-00237
• Device Sequence Number: 8665986
• Product Code: MSD
• UDI-Device Identifier: 10884521014183
• UDI-Public: 10884521014183
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/24/2024
• Device Model Number: 8888145003
• Device Catalogue Number: 8888145003
• Device Lot Number: 2310500102
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 01/20/2025
• Date Device Manufactured: 04/17/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown