MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F DIGNITY CT PORT

Model Number MICTI50041M

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for the device return for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient with picc-port on right arm, placed is 2019, not used anymore.Patient undergo device removal for end-therapy.During port reservoir removal, a complete lesion of catheter was found approx.4 cm from port connector.The distal fragment of the catheter is not identifiable within the surgical incision.An intraprocedural ultrasound examination shows the catheter inside the axillary vein, in correspondence with the axillary cavity, in a position that cannot be reached by surgical access.The ultrasound examination also allows to exclude the presence of the fragment in an extravascular site.It was therefore decided to close the skin with intradermal stitched and cyanoacrylate glue, after having removed the reservoir and the proximal fragment.The distal fragment will be removed by interventional radiologist, procedure planned.

Manufacturer Narrative

The 5f dignity port, locking collar, and approximately 4 cm of the port lumen were returned for evaluation.The remaining internal portion of the lumen was not returned.Visual inspection revealed the locking collar appears compressed, not cylindrical.It is unknown if this occurred during removal of the device or if it occurred prior to or during insertion.There was a great deal of tissue noted around the port stem, as well as under the locking collar.The tear in the lumen appears to be a v-shaped puncture that radiates outward for approximately 0.3cm to the distal end.It is not known if the lumen was cut at this point during removal of if this is the tear continued completely around the lumen.The edges of the tear were viewed under magnification and appear rough.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The device was implanted and in use for more than four years with no reported issues.A root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) include multiple precautions related to the use of the port for power injection.Failure to follow the instructions may result in port system or lumen failure.These include the use of the correct syringe size, ensure patency of the catheter prior to power injection studies, and exceeding the maximum flow rate.Device was used for treatment, not diagnosis.

• Brand Name: 5F DIGNITY CT PORT
• Type of Device: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17481158
• MDR Text Key: 320662428
• Report Number: 2518902-2023-00053
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908089639
• UDI-Public: 00884908089639
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: MICTI50041M
• Device Catalogue Number: MICTI50041M
• Device Lot Number: MNDM170 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2019
• 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): Required Intervention