BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIODYNAMICS / ANGIOVAC

    MDR report key: 6106519 · Received November 16, 2016

    Report

    Report Number
    2952363-2016-00011
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWF
    UDI-DI
    H965251860
    PMA / PMN Number
    K142593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO UPN OR LOT NUMBER WAS ORIGINALLY REPORTED, HOWEVER, BASED ON THE REPORTED DESCRIPTION OF THE DEVICE ("ANGLED") THE UPN WAS DETERMINED TO BE H965251860, AS THAT IS THE ONLY UPN CONTAINING AN ANGLED CANNULA. IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS ARE NOT REQUIRED FOR THIS EVENT, AS NO DEVICE FAILURE OR MALFUNCTION WAS INDICATED DURING THE PROCEDURE. (B)(4) IS THE CONTRACT MANUFACTURER OF THE ANGIOVAC CANNULA FOR ANGIODYNAMICS, HOWEVER NO SCAR IS REQUIRED. THE ANGIOVAC CANNULA SAMPLE WAS NOT RETURNED FOR EVALUATION SINCE THERE WAS NO REPORTED DEVICE FAILURE. IT CANNOT, THEREFORE, BE DETERMINED IF THE CANNULA WAS USED IN ACCORDANCE WITH ITS LABELING. DIRECTIONS FOR USE (DFU) IS PROVIDED WITH THIS DEVICE AND CONTAINS THE FOLLOWING STATEMENTS: WARNINGS SELECTION OF THE PATIENT AS A CANDIDATE FOR USE WITH THIS DEVICE AND FOR SUCH PROCEDURES AS IT IS INTENDED IS THE PHYSICIANS' SOLE RESPONSIBILITY. THE OUTCOME IS DEPENDENT ON MANY VARIABLES INCLUDING, PATIENT PATHOLOGY, SURGICAL PROCEDURE, AND PERFUSION PROCEDURE/TECHNIQUE. THE BENEFITS OF USE OF THIS DEVICE MUST BE WEIGHED AGAINST THE RISKS INCLUDING RISKS OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN; 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 INITIATING AND MONITORING EXTRACORPOREAL BYPASS AND BY PHYSICIANS TRAINED AND EXPERIENCED USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES; ADVERSE EVENTS: THIS DEVICE, AS DO ALL EXTRACORPOREAL BLOOD VESSEL 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 INSTRUCTIONS FOR USE ARE NOT FOLLOWED. POSSIBLE COMPLICATIONS INCLUDE THOSE NORMALLY ASSOCIATED WITH LARGE BORE SURGICAL AND/OR PERCUTANEOUS VESSEL CATHETERIZATION/CANNULATION, ANTICOAGULATION, EXTRACORPOREAL CIRCULATION AND APPLICATION OF INTRAVASCULAR INTRODUCER SYSTEMS WHICH INCLUDE BUT ARE NOT LIMITED TO: DEATH; PULMONARY EMBOLISM. (B)(4). DEVICE DISCARDED AT HOSPITAL.

    Description of Event or Problem · 1

    PATIENT STARTED PROCEDURE WITH A HEMATOCRIT BELOW 7MG/DL AND BP OF 90'S SYSTOLIC. MULTIPLE UNITS OF PRBC'S ADMINISTERED BY ANESTHESIA DURING PROCEDURE. A 26FR. GORE DRY-SEAL SHEATH PLACED IN RIJ. 17FR. RE-INFUSION CANNULA PLACED IN LIJ. ANGIOVAC CANNULA PARKED NEAR THE IVC/RA JUNCTION AND IN THE RA DURING A MAJORITY OF THE PROCEDURE. ANGIOJET WITH TPA AND CLEANER WIRE USED BY PHYSICIAN TO CLEAR MATERIAL FROM BOTH ILIAC VEINS. ONCE THE ILIAC VEINS WERE CLEAR, THE ANGIOVAC WAS ADVANCED FURTHER INTO THE IVC AND CLEANER WIRE WAS USED TO CLEAR MATERIAL REMAINING IN THE IVC. ANESTHESIA POINTED OUT DURING THE PROCEDURE THAT THE PERIPHERAL VENOUS ACCESS IN THE LEFT ARM WAS OOZING BLOOD. ANESTHESIA ALSO POINTED OUT THAT THE PATIENT HAD BLEEDING FROM SEVERAL LOCATIONS ON THE PATIENTS FACE. ANESTHESIA ALSO POINTED OUT ABOUT HALFWAY THROUGH THE PROCEDURE THAT THE PATIENT HAD AN ELEVATED ETCO2 LEVEL, A HEMATOCRIT OF 6.2MG/DL AND A PH OF 7.12. PATIENT'S VITAL SIGNS REMAINED STABLE THROUGHOUT. WITH BP ABOVE 100 SYSTOLIC AND HR IN THE 90'S. O2 SATS STAYED AT 100% THROUGHOUT THE CASE. IT IS UNCLEAR HOW MUCH INTERVENTION ANESTHESIA DID DURING THE PROCEDURE TO MAINTAIN THE PATIENT'S VITALS AT THESE LEVELS. THE PROCEDURE WAS COMPLETED AND ALL BLOOD IN THE CIRCUIT RETURNED TO THE PATIENT. THE PHYSICIAN WAS PLEASED WITH THE ANGIOGRAPHIC RESULT AND THE PATIENT'S VITAL SIGNS REMAINED STABLE. THE PATIENT WAS TAKEN BACK TO THE ICU POST-PROCEDURE. THE PHYSICIAN NOTIFIED ANGIODYNAMICS CLINICAL SPECIALIST THE NEXT MORNING THAT THE PATIENT PASSED AWAY IN THE ICU LATE THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758683 ANGIODYNAMICS / ANGIOVAC CATHETER, CANNULA AND TUBING DWF ANGIODYNAMICS H965251860 H965251860

    Patients

    Seq Age Sex Outcome Treatment
    1 Death