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

Model Number MICTI50041M

Device Problem Break (1069)

Patient Problem Infiltration into Tissue (1931)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for the device to be returned 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

Device inserted (b)(6) 2018 and used for treatment and never removed once chemo therapy ended.The device was regularly maintained with a periodic lock.During the last check the operator noted aspiration defect and subcutaneous subclavicular edema upon injection of solution.Chest x-ray showed a clean break of the catheter with migration to right heart chambers with tip end located in pulmonary artery main trunk.No signs of cardiac irritation-normal sinus rhythm, normal heart rate and blood pressure.Embolized catheter removed with interventional radiology procedure.Patient discharged the following day.

Manufacturer Narrative

The dignity port was returned with approximately 2.5cm of the lumen attached to the port stem.An additional 30+cm of the lumen was also returned.During the decontamination process a great deal of dried blood and tissue was removed from the distal end of the lumen.Visual inspection shows multiple locations that are darkened by dried blood within the lumen.An attempt was made to dislodge the occlusion by inserting a guidewire.When inserted from the distal end of the lumen the guidewire went approximately 11cm in but would not advance any further.When inserted from the opposite end the guidewire advanced only 10 cm.The dried blood and tissue could not be dislodged.It is not known if these occlusions existed at the time of the event.Under magnification it can be seen that the broken edges of the lumen are jagged, indicative of being torn and not cut.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the lumen was manufactured according to specification with no non-conformances or abnormalities.The device was implanted for almost two and a half years before the event occurred.A root cause cannot be determined but is not likely manufacture related.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.

• Brand Name: 5F DIGNITY CT PORT
• Type of Device: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11364649
• MDR Text Key: 233032082
• Report Number: 2518902-2021-00012
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908089639
• UDI-Public: 884908089639
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: MICTI50041M
• Device Catalogue Number: MICTI50041M
• Device Lot Number: MJMQ220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR