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

Model Number	MP-P5SAT
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2015
Type of Reportable Event	Malfunction
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.Potential root cause for this catheter detached failure mode (in situ for more than 4 years) is catheter pinch-off syndrome, which is cautioned in the device's directions for use (dfu).A device history record (dhr) review could not be conducted since the port packaging lot number is unknown.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 will continue to be monitored for trends.Reference (b)(4).
Event or Problem Description
On or about (b)(6) 2010, minor plaintiff underwent placement of an angiodynamics vortex product, model number: mp-p5sat and lot number: 513785.The device was implanted by dr.(b)(6) m.D., at (b)(6) medical center in (b)(6) texas, for the purpose of treating hypogammaglobulinemia.On or about (b)(6) 2015, minor plaintiff underwent removal of the port by dr.(b)(6) m.D., at (b)(6) medical center.During the procedure, dr.Miller discovered that the indwelling catheter fractured in two locations.On or about (b)(6) 2015, minor plaintiff underwent an additional procedure in an attempt to remove the fractured catheter.The procedure, performed by dr.(b)(6) m.D., was unsuccessful.A fragment of the catheter remains inside of minor plaintiff.

• 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: 22579217
• Report Number: 1317056-2025-00191
• Device Sequence Number: 9229075
• Product Code: LJT
• UDI-Device Identifier: H787MPP5SAT0
• UDI-Public: H787MPP5SAT0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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 Model Number: MP-P5SAT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown