BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FX

    MDR report key: 8762279 · Received July 4, 2019

    Report

    Report Number
    1030489-2019-00707
    Event Type
    Malfunction
    Date Received
    July 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 4, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE HANDLE BODY CAP WAS DETACHED FROM THE HANDLE BODY, WITH THE HYPOTUBE EXPOSED AND BENT AT AN APPROXIMATE 90 DEGREE ANGLE. IT IS LIKELY THIS DAMAGE WAS POST-PROCEDURAL AND OCCURRED DURING HANDLING PRIOR TO PACKAGING FOR INVESTIGATION. THE SLIDE COVER REMAINED INSERTED THE CUTTER DRIVER. THE HAWKONE WAS INSPECTED AND WAS OBSERVED THE DISTAL ASSEMBLY WAS FRACTURED APART. THE PROXIMAL SEGMENT SHOWED THE FRACTURE WAS RADIAL AND WAS LOCATED DISTAL THE ANCHOR POCKETS AND AT THE PROXIMAL EDGE OF THE COILED SEGMENT OF THE HOUSING. THE CUTTER WAS RETRACTED BACK INTO THE CUTTER WINDOW. YELLOW/GREEN DEBRIS (LIKELY PTFE FROM THE SPIDER FX CAPTURE WIRE) WAS OBSERVED WITH THE CUTTER WINDOW. THE CAPTURE WIRE WAS BENT AT 8CM FROM THE DISTAL TIP AND LOOPED AROUND AT APPROXIMATELY 46CM FROM THE DISTAL TIP OF THE CAPTURE WIRE. THE AREA OF LOOPING WAS INSPECTED UNDER MICROSCOPE AND OBSERVED THE PTFE JACKET OF THE CAPTURE WIRE WAS SCRAPED OFF LONGITUDINALLY. THE DISTAL PORTION WHICH FRACTURED OFF WHICH REMAINED ON THE 0.014" GUIDEWIRE SHOWED THEY GW TUBING OF THE HOUSING TORN AND FLAPPED DISTALLY. THE GW TUBING WAS DISENGAGED FROM THE PROXIMAL END OF THE HOUSING AND AT THE APPROXIMATE MIDDLE OF THE HOUSING THE GW TUBING REMAINED ON THE HOUSING BUT SHOWED A ZIPPER TEAR FOR THE REMAINDER OF THE SEGMENT. NO DAMAGE TO THE GW LUMEN OF THE ROTATING TIP. THE TECOTHANE IS SHOWN AS DISENGAGED FROM THE CUTTER WINDOW WITH A ROUNDED PROXIMAL EDGE. IT WAS OBSERVED THE COILED PORTION OF THE HOUSING WAS STRETCHED OUT PROXIMALLY AND EXTENDED OUT PAST THE ROUND EDGE OF THE TECOTHANE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN USED A HAWKONE H1-M DEVICE WITH A 6FR SHEATH AND SPIDER FX, DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT THERE WAS RESISTANCE FELT DURING WITHDRAWAL DAMAGE TO THE TIP WAS OBSERVED ONCE REMOVED FROM THE PATIENT. THE TIP REMAINED PARTIALLY ATTACHED WHEN REMOVED FROM THE SHEATH. ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT, THE TIP FULLY DETACHED AT THE HINGE PIN WHEN THE DEVICE WAS CLEANED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, THE DEVICE WAS NOTED TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556661 SPIDER FX CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1