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

Catalog Number	21-4471-24
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that the patient has a broken fragment of port-a-cath on the left side of the chest.During an imaging test, it was found that the tip of the port-a-cath is in an extravascular position and is short (10 cm instead of the usual 20 cm).Removal of the port-a-cath was attempted in the operating room and the removal was incomplete as the distal end was not retrieved.A scan confirmed that the catheter tip is positioned in the patient's right ventricle for which a hemodynamic assessment and a possible cardiac surgery will be done to remove the remaining portion of the catheter.There was patient involvement and patient harm.
Additional Manufacturer Narrative
B1, b2, h1 updated.One used sample was received for evaluation.Visual inspection noted the catheter end to be torn.Functional testing was performed, and free flow was observed with no leaks from the port body or catheter.The complaint of breakage can be confirmed.The probable cause is due to incorrect placement/implantation of the catheter.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• 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 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23402821
• Report Number: 3012307300-2025-11812
• Device Sequence Number: 15962226
• Product Code: LJT
• UDI-Device Identifier: 10610586032745
• UDI-Public: (01)10610586032745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 21-4471-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 63 YR
• Patient Sex: Unknown