MAUDE Adverse Event Report: COOK VANDERGRIFT INC VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number IP-S5116W-MPIS-NT

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Manufacture of this device was discontinued in november 2017.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.

Event Description

It was reported that after two years (747 days) of a cook vital-port detached silicone catheter titanium infusion port (ip-s5116w-mpis-nt) implantation, the patient suffered from thoracic pain and dyspnea.A ct scan ((b)(6) 2019) showed a torn-off port catheter (torn-off close to the port chamber) in the right ventricle reaching all the way to the right arteria pulmonalis, forming a loop in the area of the arteria pulmonalis.Additionally, at the right arteria pulmonalis, a small thrombus has been identified around the catheter.One day later the catheter was removed in the interventional radiology department.According to a letter notifying the manufacturer on 14nov2019, the device was initially implanted at university hospital (b)(6) in (b)(6) and then surgically removed by interventional angiography at (b)(6) hospital.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Updates: d2b: procode--dwf.H6-changed ec method code decs 1-device no retuned (4114).H6-changed ec method code decs 2-analysis of production records (3331).H6-changed ec results code desc1-no findings available (3221).H6-changed ec conclusion code decs1-cuase not established (4315).H6 ¿ device code:detachment of device or device component (2907).H6 ¿ patient code desc 1: dyspnea (1816), labeled.H6 ¿ patient code desc 2: chest pain (1776), labeled.H10-added summary of investigation.Manufacture of this device was discontinued in november 2017.This report includes information derived from formal investigation.Since the device was never returned for a proper evaluation, investigation results are inconclusive.Investigation summary: the vital port was not returned to cvi, therefore the quality assurance department did not perform a physical investigation.The instruction for use (ifu) was reviewed, which lists warnings, placements, indications etc: "failure to adequately anchor the port to the fascia increases the risk of catheter fracture and/or disconnection which could result in catheter migration." "do not place sutures on catheter, as catheter may be compromised.", "do not exceed the maximum flow rate; doing so may result in septum leakage, catheter displacement and/or system failure." "do not exceed the maximum pressure; doing so may result in septum leakage, catheter displacement and/or system failure." "failure to ensure patency of the catheter lumen prior to injection may result in catheter failure." "avoid contacting the catheter with sharp objects which may lead to catheter shearing." "improper catheter connection may result in catheter damage, leakage, or possible disconnection.Prior practice is recommended to ensure dexterity in connection the catheter to the port.However, do not practice with a catheter intended for implantation; doing so may result in damage to the catheter." and "use of the vital-port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter.These include, but not limited to: catheter disconnection, fracture, fragmentation." without the device to physically investigate; a defect or malfunction of the device or the manufacturing process is inconclusive.The dhr 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 dhr to indicate that this vital port was shipped to the field nonconforming.A risk assessment will be performed and documented in the complaint summary tab in trackwise.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

Catheter titanium infusion port (ip-s5116w-mpis-nt) implantation, the patient suffered from thoracic pain and dyspnea.A ct scan ((b)(6) 2019) showed a torn-off port catheter (torn-off close to the port chamber) in the right ventricle reaching all the way to the right arteria pulmonalis, forming a loop in the area of the arteria pulmonalis.Additionally, at the right arteria pulmonalis, a small thrombus has been identified around the catheter.One day later the catheter was removed in the interventional radiology department.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9454065
• MDR Text Key: 185513856
• Report Number: 2522007-2019-00025
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: IP-S5116W-MPIS-NT
• Device Lot Number: N142347
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention