BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE WIRE CERTUS

    MDR report key: 2830169 · Received November 5, 2012

    Report

    Report Number
    MW5027560
    Event Type
    Injury
    Date Received
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ST. JUDE MEDICAL S.C., INC, US DIVISION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS (B)(6) FEMALE WHO UNDERWENT A CARDIAC CATHETERIZATION ON (B)(6) 2012 FOR A FRACTIONAL FLOW RESERVE -FFR- EXAMINATION OF THE LEFT ANTERIOR DESCENDING ARTERY. THE WIRE WAS ADVANCED INTO A NARROW VESSEL. ONCE IN THE NARROW, THAT VESSEL WAS COMPLETELY OCCLUDED. PHYSICIAN ATTEMPTED TO RETRACT THE WIRE FOR THE NARROWED PASSAGE WAY, BUT THE WIRE WOULD NOT RETRACT. THE PHYSICIAN TUGGED ON THE WIRE, EVENTUALLY THE VERY SUBSTANTIAL PORTION OF THE TIP OF THE WIRE BROKE. THE TIP OF THE WIRE WAS ON THE DISTAL PORTION OF THE VESSEL. AFTER MULTIPLE ATTEMPTS OF TRYING TO RETRIEVE THE TIP OF THE WIRE, IT WAS DETERMINED TO BE TOO RISKY GIVEN THE PT'S MEDICAL CONDITION TO CONTINUE RETRIEVAL ATTEMPTS AND THE PROCEDURE WAS ABORTED. DURING THE PROCEDURE, THE PT WAS FOUND TO HAVE SIGNIFICANT PROXIMAL LEFT ANTERIOR DESCENDING DISEASE, WHICH IS WHERE THE WIRE WAS STUCK AS WELL AS CIRCUMFLEX DISEASE. BASED ON THE PT'S SIGNIFICANT CARDIAC DISEASE, THE PLAN WAS TO STABILIZE THE PT AND PERFORM A CABG PROCEDURE AT WHICH TIME THE WIRE COULD BE MORE SAFELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE WIRE CERTUS GUIDEWIRE MOUNTED SENSOR, 175 CM/0.14" - 0.36MM DQX ST. JUDE MEDICAL S.C., INC, US DIVISION C12008 123450

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention