MAUDE Adverse Event Report: ST PAUL DELTEC; PORT

Model Number	21-4455-24
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2021-13489
• Device Sequence Number: 3537106
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown