BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 4024931 · Received August 20, 2014

    Report

    Report Number
    2183870-2014-00212
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    FIVE PASSES WERE MADE IN THE COMMON FEMORAL. AS THE TURBOHAWK WAS BEING REMOVED THE NOSE CONE CAME OFF THE CATHETER AND WAS STUCK ON THE WIRE INSIDE THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE WITH THE NOSE CONE OUT OF THE BODY AND THE TECH HELD MANUAL PRESSURE.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE DISTAL TIP ASSEMBLY WAS FRACTURED AT THE PROXIMAL EDGE OF THE HOUSING (LASER-CUT) COIL. THE PROXIMAL HALF OF THE GUIDEWIRE LUMEN (GWL) WAS PULLED THROUGH THE TECOTHANE SLEEVE AND WAS TORN LONGITUDINALLY. THE REMAINING GUIDEWIRE LUMEN EXHIBITED A LONGITUDINAL TEAR BUT REMAINED ENCASED IN THE TECOTHANE SLEEVE UP THE ROTATING TIP. THE PROXIMAL 2MM OF THE ROTATING TIP'S GWL EXHIBITED SIMILAR DAMAGE. THE CUTTER HEAD ASSEMBLY EXHIBITED A FILM OF CLEAR POLYMER CONSISTENT IN APPEARANCE AND TEXTURE TO THE PET LINER OF THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501358 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN THS-LS-C 9838516

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 7F CROSSOVER SHEATH