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

Model Number	H787253020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/26/2025
Type of Reportable Event	Death
Event or Problem Description
An angiodynamics territory manager (tm) reported a patient death occurred after use of an alphavac multipurpose mechanical aspirator f18 c85.At the beginning of the case, the one-way valve on the handle was leaking blood.The device was replaced with another of the same, and the procedure was continued.At the end of the case the patient coded and subsequently expired due to a large bilateral blood clot.The physician surmised that a portion of the clot may have broken when it was being removed, causing some sort of event but he could not confirm.The physician did state to the tm that the angiodynamics device was not to blame for the poor patient outcome.
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 patient embolization and subsequent expiration cannot be confirmed given the patient centric nature of this serious adverse event (sae).There were no reports of alphavac device malfunction during the clot aspiration portion of the procedure; therefore, the device was not returned for evaluation.The physician stated that the patient's expiration is in no way associated with the alphavac device.A device history record (dhr) review of the packaging/assembly shr lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the directions for use (dfu) that is provided with this device contains the following statements: indications for use the cannula is indicated for: · the non-surgical removal of thrombi or emboli from the venous vasculature · aspiration of contrast media and other fluids from the venous vasculature the cannula is intended for use in the venous system and for the treatment of pulmonary embolism.· directions for use and manuals for the alphavac system and all related accessories should be read prior to use and devices used as indicated.· as with all medical devices, this device and ancillary equipment are to be used by trained physicians only.Specifically, this device is to be used only by medical personnel experienced with using surgical and/or percutaneous (seldinger) vascular access techniques as well as physicians trained and experienced in percutaneous, intravascular, diagnostic and interventional techniques requiring fluoroscopic or image guidance and visualization.Adverse events this device, as do all embolectomy systems and devices, has possible side effects, which include, but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the directions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, and application of intravascular introducer systems which include but are not limited to: · distal embolization of thrombus.· pulmonary embolism.· cardiac arrest.· death.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: ALPHAVAC
• 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 ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 24162774
• Report Number: 1319211-2026-00017
• Device Sequence Number: 13103609
• Product Code: LJT
• UDI-Device Identifier: 15051684025966
• UDI-Public: 15051684025966
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K240397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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 Model Number: H787253020
• Device Catalogue Number: 25-302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Sex: Female