BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1630747 · Received March 9, 2010

    Report

    Report Number
    MW5015077
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PART OF THE GUIDEWIRE WAS FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AND WAS RETAINED IN THE RIGHT CORONARY ARTERY (RCA). PT WITH PREVIOUS PCI TO RCA WAS ADMITTED WITH CHEST PAIN AND TAKEN TO THE CARDIAC CATHETERIZATION LAB. THE RCA WAS NOTED TO BE A TORTUOUS VESSEL WITH SEVERE DISEASE IN THE PROXIMAL PORTION TO A PREVIOUSLY PLACED STENT. APPROXIMATELY 10 MINUTES AFTER BALLOON INFLATION, THERE WAS A TOTAL OCCLUSION OF THE VESSEL DISTAL TO THE STENT, RESULTING IN A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. AN ATTEMPT WAS MADE TO RE-WIRE THE VESSEL; HOWEVER, THE CHOICE XS GUIDEWIRE FRACTURED AND BROKE AFTER BEING STUCK UNDER STENT STRUTS. THE RETAINED FRACTURED CATHETER WIRE WITHIN THE RCA WAS INTERTWINED WITHIN THE STENT. AFTER A SHORT INTERVAL OF CARDIOLOGY MANIPULATION OF THE WIRE AND ATTEMPT AT REMOVING THE WIRE, IT WAS DECIDED THAT THE BEST OPTION FOR THE PT WOULD BE EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). AN INTRA AORTIC BALLOON PUMP WAS INSERTED AND THE PT WAS TAKEN TO THE OPERATING ROOM FOR AN EMERGENCY CABG. THE APPEARANCE OF THE RIGHT CORONARY ARTERY APPEARED BRUISED AND A POOR OPTION FOR OPENING THE ARTERY AND REMOVING THE WIRE. HENCE, A DECISION WAS MADE TO QUICKLY PROVIDE BLOOD SUPPLY TO THE RIGHT HEART AND RIGHT VENTRICLE AS SOON AS POSSIBLE; THE BYPASS WAS SUCCESSFUL BUT THE RETAINED WIRE COULD NOT BE RETRIEVED. THIS PT HAS DONE WELL POST-OPERATIVELY AND WAS DISCHARGED FROM THE HOSPITAL 6 DAYS FOLLOWING THE PROCEDURE. CONTACTED BOSTON SCIENTIFIC MANUFACTURER ON 3/9/2010, (B) (4). DIAGNOSIS OR REASON FOR USE: USED WITH PCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CHOICE J-TIP EXTRA SUPPORT. GUIDEWIRE WITH ICE HYDROPHILIC COATING, 0.014 IN 182 DQX BOSTON SCIENTIFIC CORP. 13207832 (# NOT CONFIRMED)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention