MAUDE Adverse Event Report: ST PAUL DELTEC; PORT

Model Number 21-4455-24

Device Problem Crack (1135)

Patient Problem Implant Pain (4561)

Event Date 01/23/2019

Event Type  Injury  

Event Description

It was reported that a port was inserted to a patient on (b)(6) 2018.Patient experienced pain at insertion site for few weeks.Subsequent fluoroscopy examination (on (b)(6) 2019) revealed the need for removal due to dysfunction-leaking into pocket and along the course of the port was noted on imaging and device removed (b)(6) 2019.Patient had to undergo fluoroscopy imaging and extra surgery for removal and insertion of new port a cath.Upon removal on the mayo stand the reservoir was injected with saline and it was shown that there was a tear in the catheter itself, bout 5 cm from the hub.No patient injury was reported.

Manufacturer Narrative

Summary of investigation: actual device was available for investigation.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The sample was received with the catheter attach to the port, and a crack was found in the catheter.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the shm facility.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: DELTEC
• Type of Device: PORT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13114716
• MDR Text Key: 283094796
• Report Number: 3012307300-2021-13489
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 21-4455-24
• Device Lot Number: 88X038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1