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

Model Number	45215
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	09/10/2018
Type of Reportable Event	Malfunction
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 (b)(6) 2010, plaintiff underwent placement of the navilyst vaxcel port, reference number 45-215, lot number 1377315.The device was implanted by dr.(b)(6), md, at (b)(6), for the purpose of ongoing intravenous medications, hydration, and blood draws.On or about (b)(6) 2018, plaintiff presented herself to (b)(6) where plaintiff learned that her port was fractured and/or malfunctioned.Plaintiff was made aware by her physician that the port could not be removed.The port remains in the plaintiff's body.Plaintiff did not discover the heightened risk of the fracture related to vaxcel port defects until around (b)(6) 2023, when she saw an ad regarding the angiodynamics' defective products litigation and retained the (b)(6).
Additional Manufacturer Narrative
The customer's reported complaint description of port fractured and/or malfunctioned cannot be confirmed.No port/catheter tubing device was returned for evaluation.Without a specific reported failure mode and receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The manufacturing, packaging and sterilization of the vaxcel pasv port product lot 1377315 is likely not a contributing factor to the reported port device fracture/malfunction since the port was in situ for treatment use for more than 8 years; no device history record (dhr) review is warranted.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) provided with the port device contain the following.Statements: adverse events.Although vaxcel implantable port systems with pasv valve have been engineered for safety, there are inherent risks associated with any implantable device.These include the following: air or catheter embolism.Catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection, or rupture.Catheter occlusion or breakage caused by pinching between clavicle and first rib catheter thrombosis.Death.Drug extravasation.Embolism or catheter fragments.Fibrin sheath formation.Inflammation.Infection.Thromboembolism.System occlusions, lumen obstruction is usually evident by failure to aspirate or infuse through the lumen or inadequate flow and/ or high resistance pressures during aspiration and/or infusion.The causes may include inadequate catheter tip position, catheter kink, or catheter/vessel thrombosis, or fibrin sheath formation.Maintenance flush vaxcel implantable port system with pasv valve: using a "stop/start" pulsed technique with 10 ml of 0.9% sodium chloride or 5 ml heparinized saline (10-100 i.U./ml) using a 10 ml syringe or larger at least once every 4 weeks in order to maintain the integrity of the 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).

• Brand Name: VAXCEL
• 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
• MDR Report Key: 23568526
• Report Number: 1317056-2025-00320
• Device Sequence Number: 21299387
• Product Code: LJT
• UDI-Device Identifier: M001452150
• UDI-Public: M001452150
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K030083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 04/17/2026

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: 02/28/2013
• Device Model Number: 45215
• Device Lot Number: 1377315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female