MAUDE Adverse Event Report: ICU MEDICAL DELTEC PROPORT PORTS; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4183-24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	06/23/2023
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 reportable information becomes available.
Event or Problem Description
A product liability lawsuit was received through a watch service.The lawsuit alleges the following: on or about (b)(6) 2023, the patient's power port-a-cath, 21-4483-24, lot number 3894409 was explanted due to fracture in the catheter resulting in embolization to the right atrium and ventricle of her heart.This device was implanted for the purpose of administering chemotherapy and other treatments associated with stage iii node-positive melanoma of the skin on a lower limb on or about (b)(6) 2020.

• Brand Name: DELTEC PROPORT PORTS
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; plymouth, MN 60045 ; 2247062300
• MDR Report Key: 22546462
• Report Number: 3012307300-2025-08572
• Device Sequence Number: 15607018
• Product Code: LJT
• UDI-Device Identifier: 10610586012778
• UDI-Public: (01)10610586012778(17)241005(10)3894409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 10/05/2024
• Device Catalogue Number: 21-4183-24
• Device Lot Number: 3894409
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2019
• 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: Required Intervention
• Patient Sex: Unknown