BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 5292459 · Received December 9, 2015

    Report

    Report Number
    5292459
    Event Type
    Death
    Date Received
    December 9, 2015
    Date of Event
    November 13, 2015
    Report Date
    December 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC CARDIOLOGY
    Product Code
    NKQ
    UDI-DI
    08714729471189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE PRESENTS WITH ABNORMAL STRESS MYOVIEW FOR ELECTIVE CARDIAC CATHETERIZATION AND PERCUTANEOUS CORONARY INTERVENTION. DISTAL WIRE FRACTURE NOTED AFTER STENT DEPLOYMENT WITH SIGNIFICANT PERICARDIAL "BLUSH". ECHO POST PROCEDURE REVEALED SIGNIFICANT PERICARDIAL BLOOD WITH TAMPONADE. PATIENT TAKEN EMERGENTLY TO CVOR FOR PERICARDIAL WINDOW. RIGHT VENTRICLE FAILED DURING PROCEDURE AND PT DEVELOPED CARDIAC ARREST. PT EXPIRED DESPITE AGGRESSIVE ACLS MEASURES. GUIDEWIRE 1.7CM SHORTER WITH SLIGHT CURVATURE AT END WHEN MEASURED AND COMPARED TO A NEW INTACT WIRE. NOTIFICATION ON 12/04/2015 TO (B)(4), BOSTON SCIENTIFIC CORONARY REPRESENTATIVE (B)(4), NOTIFICATION FORWARDED TO SCIENTIFIC COMPLAINTS DEPT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812305 BOSTON SCIENTIFIC MOD SUPPORT STRAIGHT TIP GUIDEWIRE NKQ BOSTON SCIENTIFIC CARDIOLOGY PT2 GUIDEWIRE 18464862 08714729471189

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death