MAUDE Adverse Event Report: ICU MEDICAL INC PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4455-24
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/15/2023
Type of Reportable Event	Death
Event or Problem Description
Icu medical learned of a civil lawsuit filed implicating a port-a-cath ii, 21-4455-24, lot 3829680.The lawsuit alleges the following.The patient, (b)(6), underwent placement of a port in the left chest, on (b)(6) 2021 for vein access.The patient presented to (b)(6) with shortness of breath.Doctors determined she had an infection with accumulation of fluid in the lungs.The patient's port was explanted immediately after this determination on or about (b)(6) 2023.The patient passed away on (b)(6) 2023.
Additional Manufacturer Narrative
No device was returned for investigation.Due to this, no device issue was determined.If the device is returned for investigation, the device will be examined with the results sent in a supplemental report.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL INC; 6000 nathan lane north; plymouth MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; plymouth, MN 55442 ; 2247062300
• MDR Report Key: 22459677
• Report Number: 3012307300-2025-08127
• Device Sequence Number: 8315738
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: (01)10610586032707(17)240531(10)3829680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 3829680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2019
• 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: Death
• Patient Sex: Female