MAUDE Adverse Event Report: ANGIODYNAMICS, INC VORTEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	MP-P5SDT
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An anonymous reported submitted a user facility medwatch, mw5166679, for a vortex mp 5fr sil w/tray.A patient was scheduled for a removal and replacement procedure due to the implanted port not functioning properly.Upon visualizing the port at the beginning of the procedure, the surgeon discovered that the catheter had been broken in two pieces.The surgical team then proceeded to remove the catheter, following normal procedures; however, it began to shatter into different fragments.The surgical team was able to remove all of the fragments and did not implant a new port.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of catheter tubing fractured and detached cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A device history record (dhr) review of the indicated packaging/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The catheter and locking connector are provided as separate components within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with the locking connector) during the implantation procedure.Labeling review: the directions for use (dfu) that is supplied with this device, 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: infection.Occlusion.Drug extravasation (leakage).Catheter pinch-off.Fibrin sheath.Thromboembolism.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint continues to be monitored for trends.Reference (b)(4).

• Brand Name: VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21687927
• Report Number: 1317056-2025-00089
• Device Sequence Number: 18355208
• Product Code: LJT
• UDI-Device Identifier: H787MPP5SDT0
• UDI-Public: H787MPP5SDT0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 04/30/2019
• Device Model Number: MP-P5SDT
• Device Lot Number: 5020429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Unknown