BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAVAC

    MDR report key: 19931963 · Received August 7, 2024

    Report

    Report Number
    1319211-2024-00062
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    QEZ
    UDI-DI
    H787253020
    PMA / PMN Number
    K240397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT RIGHT VENTRICLE PERFORATION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). THERE WERE NO REPORTS OF ALPHAVAC DEVICE MALFUNCTION DURING THE PROCEDURE, THEREFORE, NO DEVICE WAS RETURNED FOR INVESTIGATION EVALUATION. THIS IS SUPPORTED BY THE PHYSICIAN'S STATEMENT THAT, "I DO NOT BELIEVE THIS WAS DEVICE RELATED". A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS, I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: DIRECTIONS FOR USE (10903657) ARE PROVIDED WITH THIS DEVICE AND CONTAIN 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. 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: DAMAGE TO VESSEL; VENOUS VALVE INJURY; VENTRICULAR PERFORATION; DEATH. 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).

    Additional Manufacturer Narrative · 0

    THE REPORTED 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 SENIOR TERRITORY MANAGER REPORTED THE FOLLOWING EVENT, DURING USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85: "DOCTOR (B)(6) WAS UTILIZING ALPHAVAC F18 FOR THE TREATMENT OF A PE. DURING THE CASE THE PATIENTS BLOOD PRESSURE DROPPED AND HEART RATE INCREASED. DOCTOR HAD SUSPICION OF PERFORATION AND CALLED CT SURGERY. UPON DISCUSSION AND IMAGING THEY TOOK PATIENT FOR EMERGENT SURGERY WHERE IT WAS CONFIRMED THERE WAS A PERFORATION IN THE RV OF THE HEART. DOCTOR (B)(6) STATED TO ME AFTER THE SURGERY THAT "I DO NOT BELIEVE THIS WAS DEVICE RELATED". PATIENT MADE IT OUT OF SURGERY AND IS RESPONDING WELL TO THERAPY AS OF TODAY (B)(6) 2024." DOCTOR (B)(6) HAS RECEIVED IN-SERVICE TRAINING TWICE, THE MOST RECENT TIME BEING JUST BEFORE THIS PROCEDURE; HOWEVER, THIS WAS HIS FIRST ALPHAVAC CASE. PREVIOUSLY, HE PERFORMED 2 ANGIOVAC CASES. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518230 ALPHAVAC ASPIRATION THROMBECTOMY CATHETER QEZ ANGIODYNAMICS, INC. 5752568 H787253020

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H| L| O