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

Model Number 21-4590-24

Device Problems Fluid/Blood Leak (1250); Radiation Leak (1357)

Patient Problems Neuropathy (1983); Pain (1994); Implant Pain (4561); Unintended Radiation Exposure (4565)

Event Date 05/23/2023

Event Type  Injury  

Event Description

It was reported that the 8th neoadjuvant chemotherapy for right breast cancer was completed.During the removal of the butterfly wing needle by heparin saline seal, the bolus injection was not smooth, and the patient felt tingling pain and discomfort in the neck, and the bolus injection was suspended.Contacted the interventional department to perform a digital subtraction angiograph (dsa) to find leakage near the neck.Reported to the doctor in charge and removed the catheter.

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 required.

Manufacturer Narrative

Device evaluation: a review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC PORT-A-CATH IMPLANTABLE VENOUS ACCESS
• 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: 17157806
• MDR Text Key: 317450684
• Report Number: 3012307300-2023-06284
• 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?: Yes
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Female