MAUDE Adverse Event Report: ICU MEDICAL, INC. DELTEC TITANIUM PORT-A-CATH, LOW PROFILE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4083-24
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a chest computerized tomography (ct) scan was showed a foreign body in the patient's heart.When the clinician removed the port, they found that the catheter had broken near the connection with the port.The doctor discovered the problem and performed an interventional surgery to remove the catheter in time.There was patient involvement, and there were unknown signs or symptoms experienced, and no casualties.
Additional Manufacturer Narrative
H6: the device was not returned for analysis.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.The customer provided two photos for evaluation.The photos confirmed there was breakage of the catheter.The most likely/suspected cause of the customer reported issue is related to the instruction for use (ifu) for the device provided in the previous surgery clarifying that if the catheter has tension, it will increase the possibility of kinking or fracture.Since the sample complaint was not returned for evaluation, the failure mode cannot be attributed to the manufacturing process.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.
Additional Manufacturer Narrative
D9 - date returned to mfg: 7/15/2025.H3 and h6 codes - updated.One used device was returned for investigation.The returned pictures showing that there was port with a torn catheter.The devices were visually inspected and dried blood residuals were observed.A portion of the catheter was observed inserted in the port the damage has a clean lining.The observation made on the sample is different than those of the returned image.No additional damage or anomalies were observed.The customer reported complaint of broken catheter can be confirmed.The probable cause of the damage is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: DELTEC TITANIUM PORT-A-CATH, LOW PROFILE
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22494730
• Report Number: 3012307300-2025-08268
• Device Sequence Number: 17180124
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: (01)10610586023613(17)280821(10)4426415
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 21-4083-24
• Device Lot Number: 4426415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male