BEUDAMED
    FDA Adverse Event Death Summary report: N

    WHISPER J-TIP PTCA CUTTING BALLOON

    MDR report key: 6060176 · Received October 25, 2016

    Report

    Report Number
    MW5065637
    Event Type
    Death
    Date Received
    October 25, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ABBOTT
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATH/PCI, THE GUIDEWIRE BECAME FIXED WITHIN A PREVIOUSLY PLACED STENT. INTERVENTIONAL RADIOLOGIST GENTLY WITHDREW THE GUIDE WIRE THEN NOTED ON FLUOROSCOPY THE TIP OF THE GUIDE WIRE HAD SEPARATED AND WAS EMBEDDED AND FIXED IN A STENT STRUT. PT WAS TO BE TRANSFERRED TO A UNIVERSITY SETTING FOR EXTRACTION OF THE CATHETER TIP AS SOON AS A BED BECAME AVAILABLE. SIX DAYS LATER ON THE MORNING SHE WAS TO BE TRANSFERRED, THE PATIENT CODED AND EXPIRED. THE ACUTE EVENT DID NOT APPEAR TO BE RELATED TO THE RETAINED CATHETER TIP, HOWEVER, THE PHYSICIANS COULD NOT CONFIRM WITH 100 PERCENT CERTAINTY. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706905 WHISPER J-TIP PTCA CUTTING BALLOON PTCA LOX ABBOTT 6061571

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R