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

Model Number	P5405K
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An oncologist reported an issue with a vtx sl tit 9.6fr att sil cath w 10f intr vortex port.The patient complained of pain during a chemotherapy treatment and the area turned red.Ultimately, the port was removed, and upon inspection, a crack was observed in the septum.It is assumed that this is what resulted in the extravasation of the chemotherapy agent.The port's frequency of use was reported as monday through friday for three weeks.After the port removal the patient received treatment by peripheral iv.It was reported the patient is doing well.
Additional Manufacturer Narrative
Returned for evaluation was one port with catheter tubing attached.The septum was filled with bio hazard material {blood} and there appears to be a slice/crack in the septum near the outer edge of the port.Damage to port septum was confirmed but no leak of the port septum/device was observed during testing.The customer's complaint description of damage to septum is confirmed, however,a definite root cause could not be determined from sample review.A potential root cause for the extravasation/leak during port access is the needle backing out of the septum during chemotherapy infusion.Damage to the port septum was observed on the outer edge of the septum.The use of a coring needle (i.E.Not a non-coring needle) may be another contributing factor to this type of port septum damage.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 directions for use (dfu) that is provided in the reported kit contains the following directions and precautions: contraindications angiodynamics port systems should not be implanted in the presence of known or suspected infections, bacteremia, septicemia, and peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.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).Note: septum puncture life [?] under qualified testing procedures, the septum allows up to 2,000 punctures when tested at 10 psi using a 22 gauge non-coring needle.This pressure exceeds typical levels experienced in clinical practice.Occlusion may result from clot formation inside the lumen of the catheter, precipitate formation.Inside the port from incompatible drugs, or from catheter tip placement against a vein wall or valve.Needles use of angiodynamics anti-coring (19 to 22 gauge huber point) needles in all procedures is recommended.These needles have been designed and tested to ensure that septum life is preserved.Needles are for single use only.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: 14986645
• Report Number: 1317056-2022-00091
• Device Sequence Number: 11200831
• Product Code: LJT
• UDI-Device Identifier: H787P5405K0
• UDI-Public: H787P5405K0
• Combination Product (Y/N): N
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: P5405K
• Device Catalogue Number: P5405K
• Device Lot Number: 5677902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 145 KG