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

Model Number	MICTI50041M
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During scheduled removal of the device for end of use, it is noted that the port catheter is damaged 2-3cm from the port reservoir, not yet fractured/embolized.The device was removed without further problems.
Additional 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.
Additional Manufacturer Narrative
The 5f dignity port, locking collar, and approximately 36 cm of the lumen were returned for evaluation.Visual inspection revealed the locking collar is cracked and slightly compressed.It is unknown when the damage occurred-during insertion or removal of the device.The lumen has a tear approximately 2.5 cm from the port stem.The tear extends almost the entire circumference of the lumen and has jagged edges.A great deal of blood was noted in the lumen distal to the tear.A guidewire was inserted through the tear to remove the blood but would only advance 20 cm past the tear before reaching a total obstruction.The guidewire was then inserted through the distal end of the lumen but would only advance 1 cm before stopping.It is unknown if these blood obstructions were in place at the time of the lumen tear or if the blood hardened sometime after removal.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.Medcomp engineering evaluated the complaint report and the sample.It was concluded that the catheter tear is most likely from pinch-off based on the location of the tear in relation to the port.Testing of port lumens was performed to substantiate this conclusion.All samples passed and exceeded expected performance requirements.The device was implanted and in use for more than 16 months with no reported issues.A definitive root cause could not 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.The ifu also includes information regarding pinch off.Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.Clinical signs of pinch off include difficulty with blood withdrawal, resistance to infusion of fluids, patient position changes required for infusion of fluids or blood withdrawal.Radiologic signs of pinch off are also included in the ifu along with information on how to prevent it.Device was used for treatment, not diagnosis.

• Brand Name: 5F DIGNITY CT PORT
• Common Device Name: 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: 17481017
• Report Number: 2518902-2023-00052
• Device Sequence Number: 8684888
• Product Code: LJT
• UDI-Device Identifier: 00884908089639
• UDI-Public: 00884908089639
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 02/28/2026
• Device Model Number: MICTI50041M
• Device Catalogue Number: MICTI50041M
• Device Lot Number: MPVZ670 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown