BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALPHAVAC

    MDR report key: 17692552 · Received September 6, 2023

    Report

    Report Number
    1319211-2023-00057
    Event Type
    Death
    Date Received
    September 6, 2023
    Date of Event
    August 12, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ANGIODYNAMICS
    Product Code
    QEZ
    UDI-DI
    H787253020
    PMA / PMN Number
    K211081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED FOR EVALUATION WAS ONE (1) ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. NO MANUFACTURING NON-CONFORMANCES WERE OBSERVED DURING EVALUATION OF THE RETURNED ALPHAVAC DEVICE SYSTEM. ENGINEERING EVALUATION: THE OBTURATOR WAS EXAMINED AND FOUND TO BE FREE OF DEFECTS OR ANOMALIES. NO ISSUES. THE SHEATH WAS SIMILARLY EXAMINED, WITH THE ONLY ANOMALY BEING DAMAGE TO THE DISTAL TIP. THE SOURCE OF THE DAMAGE IS SEVERE ENOUGH TO CONCLUDE IT WAS UNLIKELY TO HAVE PASSED THROUGH THE MULTIPLE INSPECTIONS UNDETECTED, AND LIKE OCCURRED DURING THE PROCEDURE. THERE WAS SIGNIFICANT BIOLOGICAL MATERIAL REMAINING INSIDE THE VALVE. FURTHER CLEANING WAS CONDUCTED TO FACILITATE FUNCTIONAL TESTING. THE CANNULA WAS EXAMINED FOR MANUFACTURING DEFECTS, BUT NONE WERE FOUND. THERE WERE SIGNIFICANT KINKS IN THE SHAFT NEAR THE DISTAL END AND JUST DISTAL OF THE HUB, INDICATING STRESS DURING USE OR ADVANVEMENT. AN ATTEMPT TO INTERFACE THE CANNULA AND SHEATH RESULTED IN PERFORMANCE AS INTENDED. THE CANNULA WAS RELATIVELY EASILY INTRODUCED AND ADVANCED THROUGH THE SHEATH IN APPROXIMATELY 2" INCREMENTS, HESITATING PERIODICALLY DUE TO THE REMAINING BIOLOGICAL MATERIAL. THE LOCKING MECHANISM IN THE SHEATH WAS ABLE TO BE CYCLED AS DESIGNED, MOVING FREELY BETWEEN LOCKED TO UNLOCKED POSITIONS. THE HANDLE ASSEMBLY CONTAINED SIGNIFICANT BIOLOGICAL MATERIAL AS WELL. THE METHOD TO CLEAN SERVED TO VERIFY FUNCTIONALITY, BY CYCLING THE HANDLE TO MOVE WATER THROUGH THE DEVICE. THE DEVICE FUNCTIONED PROPERLY, AND NO MANUFACTURING ANOMALIES WERE DETECTED. THE RETURNED SAMPLES INCLUDED AN ADDITIONAL DILATOR NOT SUPPLIED WITH THE KIT AS SOLD. ASSESSMENT OF THIS DEVICE WAS CURSORY, AND NO ADVERSE OBSERVANCES WERE MADE. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF DILATOR/OBTURATOR USED TO DELIVER CONTRAST AND IS SUSPECTED TO HAVE PERFORATED THE PA AND/OR RIGHT HEART IS NOT CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT. THERE WERE NO REPORTS OF ALPHAVAC DEVICE MALFUNCTION DURING THE PROCEDURE. NO MANUFACTURING NON-CONFORMANCES WERE OBSERVED DURING EVALUATION OF THE RETURNED ALPHAVAC DEVICE SYSTEM. THE ALPHAVAC DEVICE WAS BEING USED IN AN OFF-LABEL CAPACITY, I.E. PULMONARY EMBOLISM (PE) IN THE PULMONARY ARTERY. THE ALPHAVAC CANNULA IS INTENDED FOR USE IN THE VENOUS SYSTEM. THE END USER IGNORING ADVICE OF USING A PIGTAIL CATHETER FOR CONTRAST INJECTION AND USING THEIR OWN TECHNIQUE FOR CONTRAST INJECTION MAY BE A CONTRIBUTING FACTOR TO THE PERFORATION EVENT. DHR REVIEW OF THE PACKAGING AND ASSEMBLY SHR LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: DIRECTIONS FOR USE 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 DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT DURING THE PROCEDURE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE. REFERENCE (B)(4).

    Description of Event or Problem · 0

    AN ANGIODYANMICS' TERRITORY MANAGER REPORTED THAT APPROXIMATELY ONE HOUR INTO A PATIENT PROCEDURE USING THE ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85 TO TREAT A PULMONARY EMBOLISM IN THE PULMONARY ARTERY (PA), THE USER-FACILITY'S VASCULAR FELLOW ADVANCED THE DILATOR THROUGH THE SHEATH TO DELIVER CONTRAST AND IS SUSPECTED TO HAVE PERFORATED THE PA AND OR RIGHT HEART. STERNOTOMY WAS PERFORMED BUT ULTIMATELY THE PATIENT EXPIRED DUE TO CARDIAC TAMPONADE. THE DECISION WAS MADE NOT TO PUT THE PATIENT ON ECMO DUE TO METASTATIC CANCER DIAGNOSIS. IT WAS REPORTED THAT THE USER FACILITY'S SURGEON DID NOT FOLLOW THE ADVICE/SUGGESTION TO INSERT THE PIGTAIL THROUGH THE TOUHY AND USED THEIR OWN METHOD FOR SHOOTING CONTRAST FOR A PICTURE RESULTING IN PATIENT HARM (PUNCTURING PA AND OR RIGHT HEART).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155958 ALPHAVAC ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20 QEZ ANGIODYNAMICS UNKNOWN H787253020

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Death