BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3951118 · Received July 22, 2014

    Report

    Report Number
    2183870-2014-00182
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    WHEN REMOVING THE TURBOHAWK FROM PATIENT TO CLEAN, THE DISTAL PART OF THE DEVICE (THE NOSE CONE AND CUTTER) PULLED AWAY FROM CATHETER. THIS DID NOT CAUSE HARM TO PATIENT.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE ADAPTOR COLLAR WAS SEPARATED FROM THE DISTAL EDGE OF THE TORQUE SHAFT. THE WITNESS MARKS ON THE TORQUE SHAFT INDICATE THAT THE ADAPTOR COLLAR CRIMPS WERE ON THE DISTAL EDGE OF TORQUE SHAFT AND WOULD NOT BE AS SECURE AS A TYPICAL CRIMP LOCATION (FULLY-SEATED IN THE COLLAR CAVITY). THE DISTAL TIP ASSEMBLY AND THE TORQUE SHAFT WERE SECURED BY THE DRIVE SHAFT/ CUTTER HEAD ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427692 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN TH-LX-M 9880572

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other