MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. PRO-FUSE® CT PLASTIC POWER INJECTABLE IMPLANTABLE; PRO-FUSE CT PORT

Model Number	MRCTT96001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the device to be returned for evaluation.Device is import for export only, not sold in the us.Udi not applicable.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 or Problem Description
Catheter started to leak.
Additional Manufacturer Narrative
The port with locking collar attached to the stem and partial lumen, separate from the port body, were returned for evaluation.A video was also provided showing the port with the lumen attached.The port is being flushed and a leak at the edge of the locking collar is visible.Visual inspection of the returned device confirms the complaint as the port lumen is torn at the edge of the lock.Under magnification the tear appears partially smooth and then slightly jagged.This is indicative of being nicked/sliced with a sharp instrument, and then torn over time due to the slice.A review of the manufacture records is not possible as a definite lot number could not be provided.It is reported the device was implanted for almost one year with no reported issues.It is further reported the device was not in use for some time as the patient had completed therapy and the device was flushed every 5 to 6 weeks instead of the recommended 3 to 4 weeks.A root cause cannot be determined but is not likely manufacture related.

• Brand Name: PRO-FUSE® CT PLASTIC POWER INJECTABLE IMPLANTABLE
• Common Device Name: PRO-FUSE 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: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 20523282
• Report Number: 2518902-2024-00073
• Device Sequence Number: 9171458
• Product Code: LJT
• UDI-Device Identifier: 00884908031423
• UDI-Public: 00884908031423
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: Other
• Device Model Number: MRCTT96001
• Device Catalogue Number: MRCTT96001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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