MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

Catalog Number IP-S9010

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

This device has been discontinued and is no longer manufactured.This event is currently under investigation.Product code - ljt.510(k) - k150733.(b)(4).

Event Description

Competitor company was originally advised of this occurrence by the hospital who removed the device.During their complaint investigation they received information that the complaint device was actually a cook manufactured ip-s9010.Lot number unknown.The device was implanted in a different hospital to the complaint facility that removed the device.Event description reads: physician advised msa (competitor company) of catheter fracture."i think her portacath was inserted in (b)(6) 2016.Fractured portacath removed in the (b)(6) hospital radiology dept.On (b)(6) 2018.No complications since.

Manufacturer Narrative

Additional information: h6- ec method code desc - 1: device not returned (4114).H6- ec results code desc - 1: changed to no findings available (3221).H6- ec conclusions code desc - 1: changed to known inherent risk of device (22).Investigation-evaluation: the vital port ip-s9010 was not returned to cvi for investigation.The customer complaint/event that was reported per the trackwise entry: "competitor company was originally advised of this occurrence by the hospital who removed the device.During their complaint investigation they received information that he complaint device was actually a cook manufactured ip-s9010.Lot number unknown.The device was implanted in a different hospital to the complaint facility that removed the device.Event description reads: dr nicole gorddard advised msa (competitor company) of catheter fracture."i think her portacath was inserted in (b)(6) 2016.Fractured portacath removed in the canberra hospital radiology dept.On (b)(6) 2018.No complications since." the vital port was not returned, the quality engineering and engineering departments could not perform a physical investigation.The ifu fm-1270 was reviewed, and one of the warnings listed is "failure to adequately anchor the port to the fascia increases the risk of catheter fracture and /or disconnection which could result in catheter migration." also included in the ifu are the potential adverse events, which include "catheter disconnection, fracture and fragmentation." since the device was not returned it is inconclusive if the cause was due to the events mentioned in the ifu.Without the device to physically investigate a defect of the device or the manufacturing process is inconclusive.Cather disconnect/fracture is a known complaint mode of the vital port, and is being monitored for trends per the cvi complaint handling processes.The lot number was not provided/unknown therefore the dhr review was not performed.All process steps were complete and signed off by trained personal.A risk assessment will be performed per an assigned (b)(4).This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Competitor company was originally advised of this occurrence by the hospital who removed the device.During their complaint investigation they received information that he complaint device was actually a cook manufactured ip-s9010.Lot number unknown.The device was implanted in a different hospital to the complaint facility that removed the device.Event description reads: physician advised msa (competitor company) of catheter fracture."i think her portacath was inserted in (b)(6) 2016.Fractured portacath removed in the canberra hospital radiology dept.On (b)(6) 2018.No complications since.

• Brand Name: VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 8212878
• MDR Text Key: 132077803
• Report Number: 2522007-2018-00030
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: IP-S9010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR