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

Model Number	PSAX-10-I
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
The patient's ph low profile vortex port was inserted on (b)(6) /2022.The port was accessed three times after insertion- once for pet/ga, once postoperatively and once for lineogram.While assessing the port for ga, prior to pet scan, the clinician was unable to aspirate or flush the line.Subsequently, there was swelling over the midpoint of the line.There was a normal lineogram, with no leak, but persistent swelling 5 minutes after any infusion was commenced, along with pain.Ultimately, the device was removed and replaced with another same device.The surgeon presumes this was caused by a pin hole, along the implanted line, as it is well away from any surgical wound where there could have been inadvertent puncture of the line whilst suturing.There is no clear evidence of leak on lineogram but the line flushes well and it takes 5 minutes of infusion for the leak to become apparent.The patient was reported as stable and has not suffered from any complications following replacement of the device.
Additional Manufacturer Narrative
Returned for evaluation was one port and catheter tubing.As received, approximately 12cm of catheter tubing was attached to the port stem.The catheter tubing was cut between the 12 and 13 cm mark and approximately 15cm of catheter tubing was loose in the container.There no were no visual defects or abnormalities observed.The collar was not returned with the port sample.No leaks were detected in either the port assembly or catheter tubing.No manufacturing non-conformances were observed during port/catheter sample review.The catheter tubing met dimensional specifications.The customer's reported complaint description of pin hole/leak in catheter tubing could not be confirmed.There were no manufacturing deficiencies noted during functional testing and no leaks were observed.A root cause for the reported event could not be determined.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: 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.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: 14315061
• Report Number: 1317056-2022-00076
• Device Sequence Number: 17449019
• Product Code: LJT
• UDI-Device Identifier: H787PSAX10I0
• UDI-Public: H787PSAX10I0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 08/31/2026
• Device Model Number: PSAX-10-I
• Device Catalogue Number: PSAX10I
• Device Lot Number: 5695190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 6 YR
• Patient Sex: Unknown