MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX PORT; VORTEX LP DUAL TITANIUM PORT SYSTEM

Model Number	LVTX5213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An  ir tech manager reported an issue with a lp titanium vtx 12 fr det 12f intro port.During a placement procedure, the patient experienced an air embolism, upon removal of the wire and dilator, prior to insertion of the catheter.The patient was stabilized and the air embolism resolved by the time the interventionist intervened.The procedure was completed.After the procedure, the provider had determined after the embolism occurred that they should have used a valved sheath, and not the non-valved.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.No sheath accessory device was returned to angiodynamics for evaluation since there was no report of device malfunction during use.The customer's reported complaint description of air bubbles/embolism were introduced into the patient's vasculature cannot be confirmed given the patient centric nature of this adverse event.No sheath/dilator accessory device was returned for evaluation since there was no report of device malfunction during the procedure.Based on the event description details the likely root cause of the air embolism is end user did not sufficiently place thumb over the exposed oriffice of the sheath hub after the dilator/guidewire were removed and before the catheter tubing could be inserted.This is cautioned against in the dfu.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 item number, contains the following statements.Catheter placement considerations: unclamp guidewire and advance dilator/sheath over the exposed "j" wire.Withdraw vessel dilator and "j" wire, leaving sheath in place.Caution: to prevent air embolism, place thumb over exposed orifice of sheath.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.Potential complications.Use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: infection; occlusion; thrombophlebitis, pneumothorax; catheter malposition; migration and inadequate anchoring; hemorrhage; vessel trauma, including puncture, laceration, and erosion of vessel and the skin; catheter pinch-off (compression of the catheter between the clavicle and the first rib); hematoma; clot formation; catheter fragmentation; embolization; cardiac arrhythmia; cardiac puncture; cardiac tamponade; fibrin sheath, endocarditis; implant rejection; thoracic duct injury; thromboembolism; peritonitis; thrombosis; and drug extravasation (leakage).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).

• Brand Name: VORTEX PORT
• Common Device Name: VORTEX LP DUAL TITANIUM PORT SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15995993
• Report Number: 1317056-2022-00145
• Device Sequence Number: 5961653
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: LVTX5213
• Device Catalogue Number: LVTX5213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male