BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 6435379 · Received March 27, 2017

    Report

    Report Number
    6435379
    Event Type
    Death
    Date Received
    March 27, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 20, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO CARDIAC CATH LAB FOR A POSSIBLE PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PROCEDURE PROGRESSED TO A NEED FOR A CARDIOVASCULAR SYSTEMS INCORPORATED (CSI) ROTABLATION FOR A LAD VESSEL LESION. THE CSI VIPERWIRE ADVANCED WIRE SYSTEM WAS IMPLEMENTED SEVERAL TIMES. WHEN DRAWING BACK, THE DIAMOND HEAD LACERATED THE LAD. THE PATIENT'S BLOOD PRESSURE DROPPED REQUIRING CPR. CARDIAC SURGERY WAS CONSULTED AND THE PATIENT WAS TAKEN TO THE O.R. EMERGENTLY. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218094 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED DBEC-125 177524

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death NO