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

Model Number	MP-P5SAT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Angiodynamics received fda report reference: (b)(4).A nurse reported an issue with a vortex port (vortex mp 5fr sil w/tray pg).The patient's treatment was completed, so the port and catheter were being removed.The port was accessed for chemotherapy after placement once weekly for 1-2 months, and every three weeks after that.During the removal procedure, when the surgeon went to remove the port system, the silicone catheter portion broke apart.The following is the surgeon's operative note: "the three anchoring prolene sutures were divided and removed.The port was taken out of its subcutaneous pocket.The catheter had rough surface.With traction, the catheter came out of the tunnel, but it fractured in the subclavicular area and only the portion from the tunnel came out.We had a retained intravascular catheter fragment.There was no bleeding from the site.C-arm was used, and the catheter was found to be fractured at the mic-clavicle level; too deep to explore from a subclavian approach.Seemed to be in a stable position." the surgical wound was closed.The surgeon then discussed the case with an interventional radiologist (ir).The ir performed endovascular retrieval of the fragment that same day, and using a right femoral artery approach, the foreign body was retrieved using a snare.The patient recovered and went home later that evening.
Additional Manufacturer Narrative
The reported 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).
Additional Manufacturer Narrative
Returned for evaluation was one port with catheter tubing.As received, the port was returned with approximately 6cm of catheter tubing attached.The remainder of the catheter tubing was not returned for evaluation.The vortex mp suture filled port is sent to the customer fully assembled.As reviewed the catheter was fractured about 6 cm from the port.The mark at 5 cm is visible on the returned sample.The port was not leak tested as it was plugged with bio waste.The catheter tubing was inspected and found to be within specification for catheter id and od.The od of the port stem barbs was found to be within specification.The lock id was also found to be with specification.The port septum appears well used.The customer's reported complaint description is confirmed for fracture of the catheter tubing.Although the complaint description is confirmed, a defintive root cause for the event cannot be determined.Based on the location of the fracture from the port (~6 cm) and the worn / oval nature of the fracture, the likely root cause is pinch-off syndrome.The rest of the catheter was found to be normal in appearance and measured within specification.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: 13977652
• Report Number: 1317056-2022-00066
• Device Sequence Number: 5567580
• Product Code: LJT
• UDI-Device Identifier: H787MPP5SAT0
• UDI-Public: H787MPP5SAT0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K010767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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: 12/31/2019
• Device Model Number: MP-P5SAT
• Device Catalogue Number: MPP5SAT
• Device Lot Number: 5128249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2017
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 15 KG