MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: vital-port detached silicone catheter with introducer set dual titanium infusion port.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that, when a picture of the vital-port detached silicone catheter with introducer set dual titanium infusion port was taken under fluorescence, a leak was discovered in the port.The device was removed from the patient and replaced with another product.The leaking port was retrieved with no further issues.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation summary: the device associated with this complaint was returned and a physical investigation was performed.An approximately 3cm catheter section, port housing and catheter lock was returned.The lock was attached to the port outlet, however the catheter over the outlet tubes was not fully assembled.This was confirmed through a visual inspection through the window on the back of the port housing.There was no evidence of bruising, calcification or damage such as kicks, abrasions, punctures on the catheter surface.There were puncture marks evident in the septum.When flushed with water and needle, a leak was able to be reproduced and seen from the back of the port due to the improper assembly.The instructions for use were reviewed and per the ifu system assembly instructions: the catheter should be positioned against the port body, completely covering the port outlet tubes, this can be visualized through the window in the bottom of he port body (fig 9 ref b) the ifu also cautions that improper catheter connection may result in leakage.The device history record was reviewed, including the manufacturing and quality control activities.All process steps were complete and signed off by trained personnel.There are no signs in the device history record to indicate that this device was shipped to the field nonconforming.The complaint was confirmed through visual and physical inspection with the root cause associated with user technique.

• Brand Name: VITAL-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: 7067042
• Report Number: 2522007-2017-00040
• Device Sequence Number: 1211570
• Product Code: LJT
• UDI-Device Identifier: 00827002265042
• UDI-Public: (01)00827002265042(17)181031(10)N132758
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S7129
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 06/06/2018
• 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: 76 YR