MAUDE Adverse Event Report: ST PAUL DELTEC TITANIUM PORT-A-CATH; IMPLANTABLE PORTS

Model Number	21-4437-24
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the port device was implanted in (b)(6) 2017 for adjuvant systemic antineoplastic therapy for colon cancer, with a high risk of recurrence.Chemotherapy completed in (b)(6) 2017, device kept in place since then and regularly subjected to maintenance washings during the five years of fluorouracil.In (b)(6) 2022 (last visit), removal was requested due to the malfunction and after 5 years from the installation.During the removal procedure, evidence of cvc dislocation from the body was noted, requiring removal with an angiographic procedure.
Additional Manufacturer Narrative
Other, other text: additional information added to h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Visual observation using the unaided eye as well as 5x to 20x microscopy found the catheter had multiple small longitudinal splitting about itself at the distal end of the attached catheter as well as the distal end of the unattached length which coincided with the maximum diameter of the outlet tube bulb.The root cause of the reported issue was found to be most likely been implanted for an extended period of time.No actions were taken.

• Brand Name: DELTEC TITANIUM PORT-A-CATH
• Common Device Name: IMPLANTABLE PORTS
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14575493
• Report Number: 3012307300-2022-10487
• Device Sequence Number: 6169703
• Product Code: LJT
• UDI-Device Identifier: 00610586032663
• UDI-Public: 00610586032663
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 21-4437-24
• Device Catalogue Number: 21-4437-24
• Device Lot Number: 3261602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown