BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKONE 7F

    MDR report key: 8883650 · Received August 12, 2019

    Report

    Report Number
    9612164-2019-03341
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    UDI-DI
    00643169968509
    PMA / PMN Number
    K141801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAWKONE 7F LX WAS INSPECTED. THE TORQUE SHAFT BENEATH THE STRAIN RELIEF WAS BENT AT AN APPROXIMATE 45-DEGREE ANGLE. THE DISTAL FLUSH TOOL WAS LOCATED AT THE DISTAL END OF THE TORQUE SHAFT. THE BLACK DUCKBILLED VALVE WAS OVER THE CUTTER WINDOW. THE THUMB SWITCH WAS RETRACTED. IN ORDER TO VIEW THE CUTTER WINDOW THE THUMB SWITCH WAS ADVANCED, SO NOT TO RISK CUTTING THE BLACK DUCK-BILLED VALVE DURING REMOVAL. AFTER REMOVING THE DFT, THE CUTTER WAS LOCATED APPROXIMATELY 1CM DISTAL THE CUTTER WINDOW. TREATED TISSUE WAS NOTED AT 1CM DISTAL THE CUTTER WINDOW AND CONTINUED APPROXIMATELY 2.5CM DISTAL THE CUTTER WINDOW. FUNCTIONAL TESTING: THE CUTTER DRIVER WAS POWERED ON AND RETRACTED THE THUMB SWITCH. THE CUTTER RETRACTED AND MOTOR ACTIVATED AS INTENDED. THE THUMB SWITCH WAS ADVANCED; HOWEVER, CUTTER WAS BLOCKED AT APPROXIMATELY 1CM DISTAL THE CUTTER WINDOW. THE OBSERVED BLOCKAGE WAS LOCATED WHERE THE TREATED TISSUE WAS NOTED WITHIN THE HOUSING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED A HAWKONE H1-LS DEVICE WITH TO TREAT A 80-100MM CALCIFIED, PLAQUE 85% STENOTIC LESION IN THE PATIENT¿S PROXIMAL/DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE NOSECONE WAS NOT BEING CLEANED OUT DURING CLEANING AND THAT THE THUMBSWITCH WOULD NOT FULLY CLOSE. THE PHYSICIAN NOTICED A DIFFERENCE IN HOW THE DEVICE WAS CUTTING AN SOUNDED. THERE WERE NO ISSUES TURNING THE MOTOR ON OR OFF. THE CUTTER WAS INSIDE THE HOUSING AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A SECOND HAWKONE H1-LX DEVICE WAS TRIED AND SAME ISSUE OCCURRED HOWEVER, NO UNFAMILIAR SOUNDS WERE NOTICED. MULTIPLE ATTEMPTS TO CLEAN THE DEVICE WERE ATTEMPTED WITHOUT SUCCESS. A NEW DEVICE WAS THEN USED WITH TO COMPLETE THE ATHERECTOMY. AT THE END OF THE PROCEDURE, THE SPIDER FX WAS REMOVED WITH DEBRIS NOTED INSIDE THE FILTER. THE FILTER WAS THEN REMOVED AND PTA USING A NON-MEDTRONIC 6X100 (BARD DURADO) BALLOON WAS CARRIED OUT.  IT WAS REPORTED THAT A SMALL AMOUNT OF THROMBUS WAS FOUND AND REMOVED. THE FILTER WAS NOT USED TO REMOVE THE THROMBUS.  PART OF THE THROMBUS WAS UNABLE TO BE REMOVED. POST PICTURES WERE TAKEN AFTER WITHOUT ANY VESSEL ISSUES NOTED. PATIENT IS ON ANTICOAGULANTS AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677974 HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND 0009716628 00643169968509

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Required Intervention