BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3892451 · Received June 24, 2014

    Report

    Report Number
    2183870-2014-00149
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K103618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A BILATERAL ABOVE THE KNEE AMPUTATION (AKA) IN 2011.

    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

    THE PROCEDURE WAS RIGHT LOWER EXTREMITY ANGIO VIA LEFT COMMON FEMORAL ACCESS. ATHERECTOMY WAS PERFORMED AND THEIR WAS NO EVIDENCE OF BLEEDING OR HEMATOMA AT THE CONCLUSION OF THE PROCEDURE. A DRESSING WAS APPLIED AND THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. THE PROCEDURE ENDED AT 10:30 AM AND A CODE BLUE WAS CALLED AT 1:45PM. THE PATIENT EXPIRED. INFORMATION FROM THE SITE INDICATES THE PATIENT MAY HAVE EXPIRED FROM CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368033 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN THS-SS-CL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death