MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR

Catalog Number	21-4452-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three days after being administered chemotherapy the port chamber seemed to be leaking.The port was initially implanted in november of 2024 with no issues via the right cephalic vein for a left breast carcinoma.The port was accessed on (b)(6) 2025 and local swelling and pain in the area was seen.The infusion was stopped and radiological imaging was ordered.After fluids were injected, a large contrast extravasation was detected.The next day, the patient presented with leakage around the port chamber.On (b)(6) 2025 the port was removed from the patient.During the operation, it was observed that the port seemed to be in the right position with correct flow.Once the port was removed, it was found that the port catheter on the dorsal side was ruptured.The system was fully removed and a new port system was implanted to resolve the issue.
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.
Additional Manufacturer Narrative
D9: 3/13/2025.H6: updated.H3: one sample was received as well as nine images.As received, the catheter was seen to be separated from the port body.A section of catheter remained connected to the port body.The customer reported complaint was able to be confirmed.The probable cause of the issue remains unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; plymouth, MN 55442 ; 2247062300
• MDR Report Key: 21553061
• Report Number: 3012307300-2025-02619
• Device Sequence Number: 17262042
• Product Code: LJT
• UDI-Device Identifier: 10610586032677
• UDI-Public: (01)10610586032677(17)281026(10)4437260
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 21-4452-24
• Device Lot Number: 4437260
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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 Age: 65 YR
• Patient Sex: Female