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 Crack (1135); Fracture (1260)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577)

Event Date 09/09/2019

Event Type  Injury  

Event Description

It was reported that a patient had a port a cath placed on (b)(6) 2019.On (b)(6) 2019, 45 minutes into potassium infusion at a medical facility, the patient began complaining of burning pain to her neck and swelling.The infusion was stopped and sent for stat dye study.Ivr contrast exam finding showed early extravasation of contrast at the cephalad most portion of the catheter in the right internal jugular vein consistent with incomplete fracture.Patient had the port removed on (b)(6) 2019 and replaced with the same type of catheter.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: 17445968
• MDR Text Key: 320284708
• Report Number: 3012307300-2023-07746
• 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: 02/28/2024
• Device Catalogue Number: 21-4483-24
• Device Lot Number: 3826325
• 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: 07/11/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White