BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALPHAVAC

    MDR report key: 24993974 · Received April 26, 2026

    Report

    Report Number
    1319211-2026-00149
    Event Type
    Death
    Date Received
    April 26, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 26, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    QEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    AN ANGIODYNAMICS CLINICAL SPECIALIST MANAGER REPORTED THE FOLLOWING EVENT: "DR. (B)(6) CONTACTED OUR CLINICAL TEAM FOR VIRTUAL COVERAGE OF AN INCOMING PE PATIENT. KERRY-ANN WAS AVAILABLE AND RECEIVED INFORMATION FROM DR. (B)(6) STATING THAT THE PATIENT WAS YOUNG AND HAD RECENTLY HAD KNEE SURGERY. RIGHT HEART STRAIN WAS FOUND ON BEDSIDE ECHO, AND PATIENT HAD BEEN RESUSCITATED AT LEAST 3-4 TIMES SO FAR. TNK WAS GIVEN AND THE PATIENT WAS TRANSFERRED TO THE CATH LAB, WHERE DR. TOMA PROCEEDED WITH AN ALPHAVAC PE PROCEDURE. KERRY-ANN PROVIDED VIRTUAL INSTRUCTIONS FOR DEVICE ASSEMBLY AND HANDLE PULLS. THE PATIENT REQUIRED CPR 3 TIMES ON THE TABLE, AND THE DEVICE HAD TO BE PULLED OUT OF THE PAS. AFTER NO CLOT RETRIEVAL, AND SUSTAINED ASYSTOLE, DR. TOMA PROCEEDED TO TAKE A PA GRAM WITH A PIGTAIL CATHETER. IMAGING SHOWED NO CENTRAL CLOT BUT SCATTER PE WHICH WAS FATAL AND ALPHAVAC WOULD NOT BE USEFUL." IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY UNSTABLE BEFORE THE PROCEDURE AND CPR HAD BEEN PERFORMED MANY TIMES. ONCE PROLONGED ASYSTOLE WAS PRESENT, THE PHYSICIAN TOOK IMAGES TO VISUALLY CONFIRM IF THE ALPHAVAC DEVICE WOULD MAKE ANY DIFFERENCE FOR THIS PATIENT AND IT WAS DETERMINED THAT IT WOULD NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216099 ALPHAVAC ASPIRATION THROMBECTOMY CATHETER QEZ ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| L| D| H