MAUDE Adverse Event Report: COOK VASCULAR INC. VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

Catalog Number IP-S5116W-MPIS-NT

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/01/2015

Event Type  Injury  

Event Description

A vital port was implanted on a (b)(6) woman on (b)(6) 2010.The last radiology check of unobstructed port in use by department occurred on (b)(6) 2011.Preparations for port explantation occurred on (b)(6) 2015.Based on the findings, the catheter broke in the right upper arm, dislocating the silicon catheter in the pulmonary, causing catheter embolus.The port chamber from upper arm was explanted on the same day.Minimal invasive removal of the catheter was performed.The patient was dismissed on (b)(6) 2015 and was doing well at the time.

Manufacturer Narrative

The event is currently under investigation.

Manufacturer Narrative

A review of the complaint history device history record and the instructions for use (i fu) was conducted for the purpose of this investigation.No device was returned to assist with the investigation.In addition, no photos of the device were provided, so a visual inspection to determine the nature of the catheter fracture could not be performed.According to information provided in the complaint, a vital port catheter fractured after 5 years of implantation in the upper arm.No specific information about the implantation location was provided, though there is no indication this location does not follow that recommended in the ifu.Manufacturing records for the device were reviewed, and no evidence of manufacturing nonconformity was found.In addition, no other complaints have been filed for this device lot.Based on this information, the root cause as to why the fracture occurred is unknown.No conclusion can be drawn.Insufficient risk due in part to high detection activities, low occurrence and low seventy no further risk reduction is required at this time.We will continue to monitor for similar events.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4875027
• MDR Text Key: 6064431
• Report Number: 1820334-2015-00387
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N86986

Other Device ID Number

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2015
• Device Age: 65 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR