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

Model Number	21-4591-24
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was admitted to the hospital due to fourth-degree bone marrow suppression.During the infusion of nutrient solution, it suddenly stopped dripping.During the process of reconfirming whether the catheter was unobstructed, the patient's neck was found to be swollen, and the catheter was interrupted.The swelling was confirmed by digital subtraction angiography (dsa) in the interventional department and there was a crack in the catheter and the catheter contrast agent leaked out.
Additional Manufacturer Narrative
Other, other text: 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
No product was returned and therefore unable to confirm the reported complaint.A device history record (dhr) review reported no anomalies during the manufacturing of the reported lot number.If the product is returned, the manufacturer will reopen the complaint for further investigation.

• 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: 17019014
• Report Number: 3012307300-2023-05815
• Device Sequence Number: 6296287
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: 10610586021565
• 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): 06/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 21-4591-24
• Device Catalogue Number: 21-4590-24
• Device Lot Number: 4227823
• Was Device Available for Evaluation?: No
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female