MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The patient had a vital-port attached silicone catheter placed sometime in 2008 and was removed (b)(6) 2016.When the port was removed, it was subsequently noted that there was a sleeve still left which required a separate procedure to remove.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, device history record, and manufacturing instructions of the product was conducted.No images of the extracted locking sleeve were provided, so the device could not be inspected for signs of damage or nonconformity.Manufacturing records were reviewed, and there were no signs the device contained a nonconformity.Quality control records for the catheter lock were reviewed.No anomalies or nonconformities were detected during the quality control inspection.No other complaints have been filed for this device lot.As no product was returned and based on the limited information provided, we were unable to determine with certainty the root cause of this complaint.Per the quality engineering risk assessment (qera) no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
The patient had a vital-port attached silicone catheter placed sometime in 2008 and was removed (b)(6) 2016.When the port was removed, it was subsequently noted that there was a sleeve still left which required a separate procedure to remove.

• Brand Name: VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT
• Common Device Name: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5673841
• Report Number: 1820334-2016-00350
• Device Sequence Number: 356416
• Product Code: LJT
• UDI-Device Identifier: 00827002265110
• UDI-Public: (01)00827002265110(17)160131(10)N111053
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S6018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2016
• Device Age: 38 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 06/13/2016
• 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