MAUDE Adverse Event Report: MEDCOMP 8F DIGNITY LP CT-PORT; DIGNITY CT-PORT

Model Number	MRDP80ALN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is completed a final report will be submitted.
Event or Problem Description
Port noted to be malfunctioning.Chest x-ray showed a dense linear structure within the port catheter (green wire).
Additional Manufacturer Narrative
The guidewire fragment that was returned is a ptfe coated guidewire and measured 0.018" in diameter.The kit involved is packaged with a 0.035" uncoated, stainless steel guidewire.A review of the manufacturing and inspection procedures verified that this type/size of guidewire is not used to verify patency of the port or the catheter.The investigation could not determine when or how the segment of the wire came to be in the port lumen.The wire was not packaged in the insertion kit.

• Brand Name: 8F DIGNITY LP CT-PORT
• Common Device Name: DIGNITY CT-PORT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7095869
• Report Number: 2518902-2017-00064
• Device Sequence Number: 1895511
• Product Code: LJT
• UDI-Device Identifier: 00884908110418
• UDI-Public: 884908110418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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 Expiration Date: 01/09/2022
• Device Model Number: MRDP80ALN
• Device Catalogue Number: MRDP80ALN
• Device Lot Number: MJJS740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 06/20/2018
• 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 Age: 60 YR
• Patient Weight: 78