BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX THROMBECTOMY CATHETER

    MDR report key: 2612717 · Received June 1, 2012

    Report

    Report Number
    2183460-2012-00005
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    May 3, 2012
    Report Date
    June 1, 2012
    Manufacturer
    BAYER INTERVENTIONAL INC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A BROKEN DEVICE DURING AN ANGIOJET PROCEDURE. THE PT'S GENDER AND AGE ARE UNK AS WELL AS ANY PT MEDICAL HISTORY. AN ANGIOJET ULTRA AVX THROMBECTOMY SET WAS BEING USED IN A DECLOT PROCEDURE OF AN ARTERIAL/VENOUS (AV) FISTULA WHEN A PHYSICIAN PULLED BACK ON THE AVX DEVICE AND THE DEVICE BROKE. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE. HOWEVER, THE CASE WAS STOPPED BECAUSE THE PT'S ARM FELL OFF THE BOARD AND THE SHEATH CAME OUT OF THE PT'S ARM RESULTING IN LOST ACCESS. THE PHYSICIAN DECIDED TO DISCUSS THE CASE WITH A SURGEON. WE HAVE NOT BEEN ABLE TO OBTAIN INFO IF THE REMAINING PORTION OF THE DEVICE WAS RETRIEVED OR LEFT IN THE PT. THE IFU WARNS THE USER: "DURING THE PROCEDURE, DO NOT RETRACT THE GUIDE WIRE INTO THE CATHETER. IF RETRACTION OF THE GUIDE WIRE INTO THE CATHETER OCCURS, IT MAY BE NECESSARY TO REMOVE BOTH THE CATHETER AND GUIDE WIRE FROM THE PT IN ORDER TO RE-LOAD THE CATHETER OVER THE GUIDE WIRE." "IF RESISTANCE IS FELT DURING THE ADVANCEMENT OF THE THROMBECTOMY SET TO LESION SITE, DO NOT FORCE OR TORQUE THE CATHETER EXCESSIVELY AS THIS MAY RESULT IN DEFORMATION OF TIP COMPONENTS AND THEREBY DEGRADE CATHETER PERFORMANCE." "DO NOT PULL THE CATHETER AGAINST ABNORMAL RESISTANCE. IF INCREASED RESISTANCE IS FELT WHEN REMOVING THE CATHETER, REMOVE THE CATHETER TOGETHER WITH THE SHEATH OR GUIDE CATHETER AS A UNIT TO PREVENT POSSIBLE TIP SEPARATION." THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS ATTEMPTED TO RETRIEVE THE DISTAL PORTION OF THE BROKEN CATHETER.

    Description of Event or Problem · 1

    THEY WERE USING THIS IN A AV FISTULA AND THEY PULLED THE AVX BACK AND THE TIP CAME OFF THE CATHETER. THE TIP REMAINED IN THE AV GRAFT AND COULD NOT BE RETRIEVED. PER EMAIL (B)(4) 2012: THE DR TRIED TO SNARE THE DEVICE. THE CASE WAS STOPPED BECAUSE THE PT'S ARM FELL OFF THE BOARD AND THE SHEATH CAME OUT OF THE ARM. THEY LOST ACCESS THE DR DECIDED TO DISCUSS IT WITH THE SURGEON. THE CONTACT IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE BAYER INTERVENTIONAL INC 105039-001 124123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention