BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONE 7F

    MDR report key: 10184294 · Received June 23, 2020

    Report

    Report Number
    9612164-2020-02298
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    June 13, 2020
    Report Date
    August 5, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    UDI-DI
    00643169968509
    PMA / PMN Number
    K141801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED WITHIN A SEALED BIOHAZARD, PLASTIC BAG. WITHIN THE BAG, THE HAWKONE WAS LOOSELY CONTAINED WITHIN A NON-STERILE, SEALED POUCH, AND ANOTHER PLASTIC BIOHAZARD BAG. A DEVICE LABEL STICKER WAS ADHERED TO THE OUTSIDE OF THE PLASTIC BAG WHICH INDICATED LOT NUMBER 0010052379, CONSISTENT WITH THE REPORTED DEVICE. THE CUTTER DRIVER WAS NOT RETURNED WITH THE DEVICE. NO OTHER ANCILLARY DEVICES WERE RECEIVED. BIOLOGICAL DEBRIS WAS NOTED THROUGHOUT. THE HOUSING WAS OBSERVED TO BE BENT INTO AN ¿S¿ SHAPE. THE PROXIMAL END OF THE GUIDEWIRE LUMEN (GWL) WAS DISENGAGED, APPROXIMATELY 4.5CM DISTAL TO THE CUTTER WINDOW. THE CUTTER WAS ADVANCED APPROX. 2.5CM DISTAL TO CUTTER WINDOW . A SLIGHT BULGE WAS NOTED IN THE HOUSING AT LOCATION OF THE CUTTER. MICROSCOPIC INSPECTION REVEALED THE HOUSING GWL HAD ZIPPER TEARING. BIOLOGICAL DEBRIS WAS NOTED ON THE ROTATING DISTAL TIP, THE BIOLOGICAL DEBRIS WAS REMOVED AND DISENGAGEMENT OF THE TIP GWL WAS NOTED (PROXIMAL END). IT APPEARED LIKE THE GWL WAS PULLED DISTALLY. INSPECTION OF THE HOUSING BULGE REVEALED BIOLOGICAL DEBRIS WAS DISTAL TO THE CUTTER. THE INNER LASER DRILLED COILS WERE DAMAGED. NO TEARING OF TECOTHANE WAS NOTED. THE DEVICE WAS CONNECTED TO A KNOWN GOOD CUTTER DRIVER. AN ATTEMPT WAS MADE TO RETRACT THE CUTTER UNSUCCESSFULLY BECAUSE THE CUTTER WAS CAUGHT BY THE INNER LASER DRILLED COILS. NO DAMAGE WAS NOTED TO THE CUTTER WINDOW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 7FR SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. PRE-DILATION WAS PERFORMED. TIP DAMAGE IS REPORTED. THE NOSECONE IS REPORTED AS DAMAGED. NO SEPARATION OCCURRED AT THE HINGE PIN. THE DEVICE WAS USED TO TREAT THE PATIENT BEFORE TIP DAMAGE WAS NOTED. NO COMPONENTS DETACHED. IT IS UNKNOWN IF ANY CHIPS WERE MISSING FROM THE CUTTER. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. IT IS UNKNOWN THE POSITION OF THE CUTTER DURING DEVICE REMOVAL FROM THE PATIENT. THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS ENDED WITH REMOVAL OF THE ARTERIAL SHEATH INTACT WITH THE SITE SEALED WITH MANUAL COMPRESSION, THERE WAS NO FURTHER PATIENT TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648690 HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND H1-LX 0010052379 00643169968509

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR