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

Model Number	MP-P5PTH787MPP5PT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Medical device site infection (4845)
Date of Event	02/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's reported complaint description of patient infection and thrombosis cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port device was returned for evaluation since there was no report of port device malfunction, damage or performance issue during in situ use/treatment.A device history record (dhr) review of the indicated packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Certificate of conformance for the sterilization process for the reported packaging lot was verified to be approved at time of distribution.There have been no other reported complaints for the indicated packaging lot for similar patient infection and thrombosis issue.The port was implanted into the patient 37 days prior to the patient's infection.There was no report of port device malfunction or performance issue during the implant procedure/use.If the manufacturing/packaging/sterilization of the port device in question was to contribute to an infection in the patient it would have likely occurred shortly after the implant date and not 37 days later.Device directions for use (dfu) cautions that each access of the port should be performed using aseptic technique, following the institutions universal precautions.There is no indication from the reported complaint that the manufacturing/packaging/sterilization of the port device could have contributed to the patient's infection.Infection and thrombosis are cautioned in the device dfu as a potential complication of port system use.Labeling review: the directions for use (dfu) that is provided with the vortex port device contains the following statements: product description.Ports manufactured by angiodynamics are supplied as sterile devices and are intended for single patient use only.Indications for use.The angiodynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion.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: - clot formation.- embolization.- infection.- implant rejection.- thrombophlebitis.- thromboembolism.- thrombosis.System maintenance: venous systems.After use, the port should be flushed with at least 20 ml of normal saline.This should be followed by a "heparin lock".If the port is not being used, a "heparin lock" should be administered every 4 weeks.Arterial systems.After use, the port should be flushed with at least 20 ml of normal saline.This should be followed by a "heparin lock".Positive pressure should be maintained on the syringe plunger at all times to minimize reflux of blood into the catheter.If port is not being used, a "heparin lock" should be administered once a week.Peritoneal systems.The intraperitoneal port should be flushed after use, or once a month if not in use, with 10 ml of heparinized saline at a concentration of 10 units/ml.General guidelines.· each access of an angiodynamics port should be performed using aseptic technique.· the needle should be advanced through the septum until it contacts the base of the port body.Once positioned in the septum, the needle should not be rocked or tilted.Such movement may cause septum damage.· at no time should the system be left open to air.Tubing clamps should be used to prevent inadvertent air embolism.· when infusing into an angiodynamics port system, do not exceed 40 psi.· do not use a syringe size smaller than 10 ml.Smaller syringes may create an overpressurized system.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).
Event or Problem Description
On or about (b)(6) 2017, plaintiff underwent placement of an angiodynamics vortvtx catheter product, model number mp-p5pt, lot number 5073592.The port catheter was implanted by dr.(b)(6), at (b)(6).In or about (b)(6) 2017, plaintiff presented to the (b)(6), with concerns related to her port site.Her medical team determined that she had developed an infection as well as blood clots in the right internal jugular.The defective port was subsequently removed.

• Brand Name: VORTEX
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 603 queensbury avenue; queensbury, NY 12804
• MDR Report Key: 25089353
• Report Number: 1319211-2026-00162
• Device Sequence Number: 21329665
• Product Code: LJT
• UDI-Device Identifier: H787MPP5PT0
• UDI-Public: H787MPP5PT0
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K033473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• 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): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: MP-P5PTH787MPP5PT0
• Device Lot Number: 5073592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Other; Required Intervention
• Patient Sex: Unknown