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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Radiation Leak (1357); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2023-05317
• Device Sequence Number: 17682949
• Product Code: LJT
• UDI-Device Identifier: 10610586021541
• UDI-Public: 10610586021541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Unknown