BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPEEDIOR ANGIOJET CATHETER

    MDR report key: 465944 · Received June 12, 2003

    Report

    Report Number
    2183460-2003-00004
    Event Type
    Death
    Date Received
    June 12, 2003
    Report Date
    June 11, 2003
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HOSPITALIZED AFTER FRACTURE OF THE RIGHT FEMORAL NECK. DURING SURGERY FOR TOTAL HIP REPLACEMENT, THE PT DEVELOPED RESPIRATORY DISTRESS, AND THE PAO2 DROPPED TEMPORARILY FROM 110 TO 75 MMHG. AFTER COMPLETING SURGERY, PT WAS HEPARINIZED AND DIRECTLY REFERRED FOR COMPUTED TOMOGRAPHY (CT) AT THE DEPT. THE CT SCAN REVEALED MASSIVE PULMONARY EMBOLISM; THE RIGHT UPPER AND MIDDLE LOBE ARTERIES WERE OCCLUDED, AND THE SEGMENTAL ARTERIES OF THE LOWER LOBE WERE PARTIALLY OBSTRUCTED. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) VIA A RIGHT FEMORAL VEIN ACCESS CONFIRMED THE DIAGNOSIS, AND IT WAS DECIDED TO PERFORM TRANSVENOUS PULMONARY EMBOLECTOMY. A 6-F ANGIOJET XPEEDIOR CATHETER (POSSIS MEDICAL INC, MINNEAPOLIS, MN, USA) WAS INTRODUCED INTO THE RIGHT PULMONARY ARTERY OVER A 0.035-INCH TEFLON GUIDEWIRE (RADIOFOCUS M, TQRUMO, TOKYO, JAPAN) BY AN EXPERIENCED INTERVENTIONAL RADIOLOGIST FAMILIAR WITH THIS DEVICE (-100 THROMBECTOMIES). THE SYSTEM WAS ACTIVATED INSIDE THE RIGHT CENTRAL PULMONARY ARTERIES FOR A TOTAL OF 4 MINUTES ACCORDING TO THE MFR'S INSTRUCTIONS. THE ANGIOGRAM REVEALED A REDUCTION IN THROMBUS VOLUME WITH RESIDUAL MATERIAL INSIDE THE MIDDLE LOBE ARTERY AND PERSISTING OCCLUSION OF THE UPPER LOBE ARTERY. IT WAS DECIDED TO CONTINUE THE THROMBECTOMY MANEUVER. FURTHER THROMBUS MATERIAL WAS BEING REMOVED FROM THE DILATED RIGHT MIDDLE LOBE ARTERY (8MM ESTIMATED VESSEL DIAMETER) WHEN SUDDEN, MASSIVE ARTERIAL BLEEDING OCCURRED THROUGH THE TRACHEAL TUBE. AT THIS TIME, THE DEVICE HAD BEEN ACTIVATED FOR A FURTHER 2 MINUTES. NO ABNORMAL RESISTANCE IN MANEUVERING THE CATHETER WAS NOTED, AND NO UNDUE FORCE WAS APPLIED WHILE PLACING THE CATHETER TIP INSIDE THE CLOT. FLUOROSCOPY REVEALED A SLOWLY GROWING OPACITY NEAR THE RIGHT MIDDLE LOBE ARTERY, WHICH WAS CORRELATED TO THE MASSIVE BLEEDING. THE DRAMATICALLY DESTABILIZING CLINICAL STATE OF THE PT DID NOT ALLOW ADD'L ANGIOGRAMS OR ANY ATTEMPTS TO OCCLUDE THE ASSUMED PERFORATION. WITHIN 10 MINUTES, ARTERIAL PRESSURE DROPPED FROM 140/80 TO 80/40 MMHG AND THE HEART RATE INCREASED TO 120 BPM UNTIL SUDDEN ASYSTOLE. REPEATED CARDIOPULMONARY RESUSCITATION FAILED. POST-MORTEM, THE EXACT LOCATION AND MORPHOLOGY OF THE VESSEL LESION COULD BE NOT BE IDENTIFIED, AS THE PT'S FAMILY EXPLICITLY REJECTED AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPEEDIOR ANGIOJET CATHETER THROMBECTOMY CATHETER MCW POSSIS MEDICAL, INC. XPEEDIOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death