BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3935933 · Received July 15, 2014

    Report

    Report Number
    2183870-2014-00177
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    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

    THE NOSECONE OF THE TURBOHAWK BROKE OFF INSIDE OF THE PATIENT AND HAD TO BE SNARED MULTIPLE TIMES THROUGH AN 11F SHEATH. SURGICAL INTERVENTION WAS REQUIRED TO CLOSE UP THE ARTERY WHERE THE SHEATH WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414398 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN TH-LX-M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention