MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC PORT-A-CATH PORTS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4034-24
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Date of Event	11/23/2005
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
A product liability lawsuit was received through a watch service.The lawsuit alleges the following: on or about (b)(6) 2005, the patient¿s deltec low profile port a cath, item number 21 4034 24 and lot number m21192, was explanted due to a catheter component of the implanted port having fractured and embolized, migrated through the heart, and lodged in the left descending pulmonary artery.The device was implanted for the purpose of administering chemotherapy as treatment for breast cancer on or about (b)(6) 2005.

• Brand Name: DELTEC PORT-A-CATH PORTS
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24983936
• Report Number: 3012307300-2026-04183
• Device Sequence Number: 18566538
• Product Code: LJT
• UDI-Device Identifier: 10610586023811
• UDI-Public: (01)10610586023811(17)080420(10)M21192
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 04/20/2008
• Device Catalogue Number: 21-4034-24
• Device Lot Number: M21192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Life Threatening
• Patient Sex: Unknown