BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION DEVICE

    MDR report key: 3883590 · Received June 19, 2014

    Report

    Report Number
    2183870-2014-00141
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 (B)(4) 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

    DEVICE EVALUATION: THE TURBOHAWK TORQUE SHAFT WAS LOADED THROUGH THE GUIDE SHEATH AND THE DISTAL TIP ASSEMBLY WAS PARTIALLY EXPOSED BEYOND THE GUIDE SHEATH'S DISTAL TIP. THE GUIDE SHEATH'S DISTAL TIP EXHIBITED A LONGITUDINAL CREASE BUT NO EVIDENT TEARING. THE EXPOSED SECTION OF THE TURBOHAWK GUIDEWIRE LUMEN (GWL) DID NOT EXHIBIT ANY DAMAGE RELEVANT TO THE REPORTED EVENT. THE DISTAL TIP ASSEMBLY WAS PULLED DISTALLY AND THE DISTAL TIP ASSEMBLY DISTAL TO THE PROXIMAL EDGE OF THE HOUSING WINDOW WAS FOUND SEPARATED FROM THE REST OF THE TURBOHAWK. THE DISTAL FRACTURE FACE EXHIBITED MATERIAL DEFORMATION OF THE PLATINUM/IRIDIUM HOUSING INDICATING A DUCTILE TEAR AT THE PROXIMAL EDGE OF THE HOUSING WINDOW. THE REMAINDER OF THE GWL WAS NOT TORN. THE DRIVE SHAFT AND CUTTER HEAD ASSEMBLY WERE INTACT AND COMPLETE.

    Description of Event or Problem · 1

    THE LESION WAS IN THE RIGHT COMMON FEMORAL. THE TURBOHAWK WOULD NOT CROSS LESION AT INITIAL INSERTION. THE PHYSICIAN THEN PRE-DILATED WITH A 5MM BALLOON AND RE-INSERTED THE TURBOHAWK, BUT IT STILL WOULD NOT CROSS. THE PHYSICIAN TRIED TO TORQUE THE DEVICE BUT IT WOULD NOT TORQUE. THE PHYSICIAN WENT TO REMOVE THE TURBOHAWK OUT OF THE PATIENT AND THE NOSECONE BROKE OFF IN SHEATH AND SEPARATED FROM THE CATHETER. THE NOSECONE REMAINED IN THE SHEATH AND CAME OUT OF THE PATIENT WHEN THE SHEATH WAS REMOVED. NO ADVERSE EVENT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359785 TURBOHAWK PERIPHERAL PLAQUE EXCISION DEVICE CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN TH-LX-M 9866505

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other POWERCROSS BALLOON| COOK .014 HYDRO APPROACH WIRE