BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / ANGIOVAC

    MDR report key: 6145665 · Received December 5, 2016

    Report

    Report Number
    2952363-2016-00012
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DWF
    UDI-DI
    H965251850
    PMA / PMN Number
    K142593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CONFIRMATION IN THE EMAIL FROM THE TERRITORY MANAGER (TM), THE CANNULA WAS A STRAIGHT CANNULA (UPN H965251850). BASED ON THE ATTACHED SHIP HISTORY REPORT (SHR), THE ONLY LOT EVER SHIPPED TO THIS CUSTOMER FOR THIS UPN WAS 4943462. ALTHOUGH A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR THIS COMPLAINT, A REVIEW OF THE DHRS ARE NOT REQUIRED FOR THIS EVENT. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING THE PROCEDURE. DUKE EMPIRICAL IS A CONTRACT MANUFACTURER OF THE ANGIOVAC CANNULA FOR ANGIODYNAMICS, NO INFORMATIONAL 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. BASED ON THE REPORTED EVENT DESCRIPTION, THE ROOT CAUSE FOR FURTHER MEDICAL INTERVENTION (SURGERY) WAS THE DOCTOR'S DECISION DUE TO A LARGE CLOT OBSERVED IN THE RIGHT PULMONARY ARTERY. 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. (B)(4).

    Description of Event or Problem · 1

    ELDERLY PATIENT UNDERGOING ANGIOVAC THROMBECTOMY STATUS POST DVT AND AN OCCLUDED VENA CAVA. PATIENT HAD A FILTER IN PLACE WHICH WAS PLACED APPROXIMATELY 3 WEEKS PRIOR TO THE CASE. DURING THE PRE-CASE PLAN THERE WAS A DISCUSSION OF A SUPRA-RENAL FILTER TO PREVENT CLOT FROM GOING AROUND THE CANNULA AND ENDING UP IN THE PATIENT'S LUNGS. DURING THE CASE HOWEVER, THE LANDING ZONE WASN'T AMENABLE FOR THE SUPRA-RENAL IVC FILTER PLACEMENT. ACCESS POINTS FOR THIS CASE WERE RIGHT INTERNAL JUGULAR FOR ASPIRATION AND LEFT INTERNAL CANNULA FOR REINFUSION. ADDITIONALLY, THE LEFT FEMORAL VEIN WAS ACCESSED FOR IMAGING AND ANCILLARY DEVICES. INITIAL FLOW RATES WERE EXTREMELY POOR IN THE PERI-HEPATIC CAVA, ONLY 500 CC/MIN AT 1500 RPMS. ANGIODYNAMICS CLINICAL SPECIALIST VOICED HIS CONCERNS AT THIS, ESPECIALLY SINCE HE COULDN'T ACCOUNT FOR THIS EXTREMELY LOW FLOW RATE. THE PATIENT WAS THEN GIVEN A LITER OF SALINE TO INCREASE HIS CIRCULATING VOLUME. THE CASE THEN PROCEEDED WITH A FLOW RATE OF 1.5L/MIN. THE FLOW RATES CONTINUED TO BE A PROBLEM THROUGHOUT THE CASE. A CLEANER WIRE WAS USED IN THE VENA CAVA AND A FEW MINUTES LATER THE PATIENT'S END TIDAL CO2 WENT DOWN ALONG WITH HIS OXYGEN SATURATION. IMAGING OF THE PA SHOWED A LARGE CLOT IN THE RPA, SO AFTER SOME DISCUSSION WITH CT SURGERY THE PATIENT UNDERWENT AN OPEN THROMBECTOMY. THE PATIENT DID SURVIVE SURGERY AND PRESUMABLY WILL BE OK. THE ANGIOVAC CANNULA WAS NOT DAMAGED DURING THIS CASE AND THE CLINICAL SPECIALIST COULD OBSERVE NO DEFECTS IN THE DEVICE. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796422 ANGIODYNAMICS / ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS 4943462 H965251850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R