MAUDE Adverse Event Report: ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number 21-4483-24

Device Problems Detachment of Device or Device Component (2907); Separation Problem (4043)

Patient Problem Swelling/ Edema (4577)

Event Date 05/30/2023

Event Type  Injury  

Event Description

It was reported that a patient had a chemo port placed on (b)(6) 2019.The device has not been used for chemotherapy in the last few years.On (b)(6) 2023 the patient was being flushed at a medical facility and noticed swelling in the neck or the chest wall.An x-ray was done which showed upon further review of the images, that there was detachment of the proximal portion of the mediport tubing from the hub with separation of approximately 2.3 cm.Patient underwent surgical removal of device on the same day.The outcome of the event was resolved.

Manufacturer Narrative

No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17445963
• MDR Text Key: 320282324
• Report Number: 3012307300-2023-07743
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032776
• UDI-Public: 10610586032776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2023
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3703678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: Black Or African American