MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIOVAC; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	H965252810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an issue with an angiovac circuit with bubble trap.It was reported that during assembly of the cec circuit for thromboaspiration, it was found that the ring had become detached, preventing the nut from being tightened and loosened to insert the mandrel.It was reported that this resulted in a less effective procedure and longer intervention time.It was later reported that the patient experienced an intraoperative iatrogenic pulmonary embolism during the procedure, after removal of the angiovac catheter, when the clot became dislodged.Thromboaspiration was then performed using an inari device.Currently, the patient is in good clinical health and is taking anticoagulants for her bilateral pulmonary embolism.The physician reported that there is no direct link between the malfunction of the angiovac device and the patient adverse event.
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).

• Brand Name: ANGIOVAC
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 25094095
• Report Number: 1319211-2026-00171
• Device Sequence Number: 9990739
• Product Code: DWE
• UDI-Device Identifier: H965252810
• UDI-Public: H965252810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: H965252810
• Device Lot Number: 5839933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 05/14/2026; 05/14/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/11/2026; 06/12/2026
• 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: Hospitalization; Required Intervention; Other; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female