MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH P.A.S. PORT ELITE; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Model Number 21-4590-24

Device Problems Fluid/Blood Leak (1250); Radiation Leak (1357); Infusion or Flow Problem (2964)

Patient Problem Swelling/ Edema (4577)

Event Date 04/23/2023

Event Type  Injury  

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.

Event Description

It was reported that a patient was admitted to the hospital due to fourth-degree myelosuppression.During the infusion of nutrient solution, the infusion "suddenly stopped", and the patient's neck was found to be swollen during the process.The catheter was confirmed to be broken and cracked via digital subtraction angiography (dsa) at the radiology department.Leakage of contrast medium from the catheter.No adverse effects reported.

Manufacturer Narrative

One device was returned for investigation.Visual inspection occurred and a section of the catheter was found to be attached to the port with no scuffs, pinch marks, cracks, crazing cuts or other damages that could contribute to the failure mode.A leak test was performed and the device showed no leaks were present.The reported complaint is not confirmed.Root cause cannot be associated with manufacturing process since the failure could not be reproduced.No corrective actions are required.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: DELTEC PORT-A-CATH P.A.S. PORT ELITE
• 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: 16889541
• MDR Text Key: 314771876
• Report Number: 3012307300-2023-05317
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586021541
• UDI-Public: 10610586021541
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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 Model Number: 21-4590-24
• Device Catalogue Number: 21-4590-24
• Device Lot Number: 4227823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR