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

Catalog Number	21-4483-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Airway Obstruction (1699); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that several plastic parts of the system detached and entered the patient's blood vessels.The patient received a port-a-cath and came in for a check-up because the tube appeared to have detached from the chamber.However, the x-ray showed that the catheter was broken in several places and that pieces of the catheter were in the lung.The port could not be removed because there was a high risk of more pieces of tubing embolizing into the lungs.The port must be removed surgically.As immediate measures the reporter enumerates the following: the patient was admitted to the hospital.The detached pieces of tubing from the lungs were retrieved using catheter technology via a transfemoral venous access in the cardiac catheterization laboratory (ccl).The removed parts were preserved and secured in tubes.Additionally, further action taken was surgical removal of the remaining defective port-a-cath system is planned and the patient will be called in for this.The incident happened during the revision of the port a cath.This product was inserted into the patient on (b)(6) 2024.There was patient involvement and adverse event reported.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.Device evaluation: one photo and one used device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis the customer reported complaint was confirmed.The probable root cause is due to incorrect placement or implantation of catheter.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23058103
• Report Number: 3012307300-2025-10651
• Device Sequence Number: 18334325
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: (01)10610586032776(17)280321(10)4387747
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Catalogue Number: 21-4483-24
• Device Lot Number: 4387747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOVALGIN 500MG; TEMESTA EXP. 1MG
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown