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

Model Number	44032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
On or about on (b)(6) 2021, plaintiff underwent placement of an angiodynamics vortex implantable port, model number: h787p5455k0, lot number: 5670753.The device was implanted by dr.(b)(6), m.D., at (b)(6), to facilitate chemotherapy treatment.On or about on (b)(6) 2023, plaintiff presented to (b)(6), with complaints of a fever.On or about on (b)(6) 2023, plaintiff received a call from her doctor that her blood cultures drawn on (b)(6) 2023, came back positive for a bacterial infection, and that she needs to go to the emergency room.On or about on (b)(6) 2023, plaintiff presented to the emergency room at (b)(6), for further evaluation as directed by her doctor.After evaluation, plaintiff's medical team determined that the vortex was the source of the infection and that the implant needed to be removed.On or about on (b)(6) 2023, due to her infected vortex port catheter, plaintiff underwent surgical removal of the defective device, which was removed by (b)(6), m.D., at (b)(6).
Additional Manufacturer Narrative
The customer's reported complaint description of patient infection 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 use.A device history record (dhr) review of the indicated packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Sterilization load release records were reviewed for the reported packaging lot; no issues were observed.The port was implanted into the patient more than 17 months prior to the patient's infection.There was no report of port device malfunction or performance issue during 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 more than 17 months later.Device direction for use 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 is 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: infection, implant rejection.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 will continue to be monitored for trends.Reference (b)(4).

• Brand Name: XCELA
• 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: 21560507
• Report Number: 1317056-2025-00059
• Device Sequence Number: 4373561
• Product Code: LJT
• UDI-Device Identifier: H965440320
• UDI-Public: H965440320
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2025

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: 03/31/2026
• Device Model Number: 44032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Female