BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 8451214 · Received March 26, 2019

    Report

    Report Number
    8451214
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 19, 2019
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OBITAL ATHERECTOMY DEVICE GOT STUCK IN LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION AND WAS RETRIEVED WITH EVIDENCE OF PERFORATION OF THE ARTERY. GRAFTMASTER STENT WAS PLACED IN LAD ARTERY. VIPERWIRE: REF # GWC-12325LG-FLP. LOT # 11034675. DIAMONDBACK 360: REF # DBEC-125. LOT # 250394.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244589 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 250394

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA Required Intervention