MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX PORT; VORTEX TR SINGLE TITANIUM PORT SYSTEM

Catalog Number SSDX16I

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Emotional Changes (1831); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of catheter tubing fractured and detached cannot be confirmed, no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for the type of failure mode reported (catheter tubing fractured and detached) is pinch-off syndrome, which is cautioned against in the device dfu as potential complication.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, which is supplied to the user with this catalog number, contains the following statements.Catheter placement considerations: warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.After implantation and during system use each access to the vortex® mp port system should be performed using aseptic technique.Use only non-coring needles with the vortex® mp port system.The noncoring needle design helps maintain the self-sealing septum.Under qualified procedures the vortex® mp port system allows up to 2,000 punctures with an angiodynamics® 22 gauge noncoring needle, when tested at 10 psi.This pressure exceeds the typical levels experienced in clinical practice.· do not use a syringe smaller than 10 ml.Smaller syringes may create an over-pressurized condition in the system.Warning: for chest placement, avoid medial catheter placement.Instructions for implantation of the vortex® mp port into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route to the subclavian vein.Note: a port placed too deeply may be difficult to palpate and access.Potential complications: use of the system involves potential risks associated with any implanted device or indwelling catheter.They include, but are not limited to: extravasation: catheter fracture, including "pinch-off syndrome".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Event Description

(b)(4), a legal group, notified angiodynamics of an incident regarding a triumph vortex port.On or about (b)(6) 2018, plaintiff underwent placement of the triumph vortex port, det w/10f intro device.The device was implanted by dr.(b)(6) , m.D., at (b)(6) , for the purpose of ongoing chemotherapy.On or about (b)(6) 2019, plaintiff presented himself to (b)(6) for port removal.Plaintiff's medical team determined that plaintiff's port was malfunctioning and causing extreme pain to plaintiff.During removal of the vortex port on (b)(6) 2019, plaintiff's medical team noticed that the catheter segment appeared too short.An x-ray was taken, and it revealed that part of the catheter broke off and had traveled to plaintiff's heart.Plaintiff underwent a second surgery on an emergency basis to remove the foreign fragment from his heart on (b)(6) 2019.As a result of having the vortex implanted, plaintiff has experienced significant mental and physical pain and suffering, has sustained permanent injury, permanent and substantial physical deformity, has undergone corrective surgeries, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses.

• Brand Name: VORTEX PORT
• Type of Device: VORTEX TR SINGLE TITANIUM PORT SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17643858
• MDR Text Key: 322200822
• Report Number: 1317056-2023-00110
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787SSDX16I0
• UDI-Public: H787SSDX16I0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: SSDX16I
• Device Lot Number: 5084589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• 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): Life Threatening; Required Intervention
• Patient Sex: Male