MAUDE Adverse Event Report: ST PAUL DELTEC; PORT-CATHETER,IMPLANTED,SUBCUTANEOUS,INTRAVASCULAR

Model Number 21-4483-24

Device Problem Peeled/Delaminated (1454)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687)

Event Date 03/08/2021

Event Type  Injury  

Event Description

Information received a smiths medical implantable ports|deltec power port-a-cath ii ports hub came apart.This was discovered during infusion one liter of fluid on (b)(6) 2021 when the infusion took all day and patient was experiencing chest pain.Intervention radiology study was performed and revealed the port had come apart at the catheters connection hub.The port was removed by a general surgeon along with vascular surgeon.The intervention was open exploration of the inter jugular vein to remove the catheter tip.This required extra recovery time and new port needed to be placed.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.One used portal was returned with a section of catheter over the outlet tube and an unattached length of catheter measuring approximately 8.75 inches in length.Visual observation using the unaided eye as well as 5x to 20x microscopy found the catheter had broken away from itself where it had been connected to the portal at the maximum diameter of the outlet tube bulb.The reported issue was confirmed.Tool markings were also noticed at the diameter of the ultra-lock.These visual characteristics are consistent with the catheter having been able to move relative to the port body.When the catheter bends at the outlet tube a crease can form in the catheter material.If this occurs often enough a crack or multiple cracks can form which may eventually lead to a complete fracture of the catheter.The root cause was not determined.

• Brand Name: DELTEC
• Type of Device: PORT-CATHETER,IMPLANTED,SUBCUTANEOUS,INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11615300
• MDR Text Key: 243812229
• Report Number: 3012307300-2021-02840
• 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: KO726570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: 21-4483-24
• Device Catalogue Number: 21-4483-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White