BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARWAY RX

    MDR report key: 1251669 · Received December 2, 2008

    Report

    Report Number
    1219977-2008-00008
    Event Type
    Death
    Date Received
    December 2, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CAME INTO THE CATH LAB WITH AN ANTERIOR MI. THROMBUS WAS FOUND IN THE PROXIMAL LAD, THERE WAS AN OCCLUSION IN THE MID RCA. AN ASPIRATION CATHETER WAS USED, FOLLOWED BY A PRE-DILATION WITH A 2.5 MM BALLOON. A 2.0 X 20MM CLEARWAY WAS USED TO DELIVER THE REPRO BOLUS. AFTER 10-15 SECONDS, THE PATIENT FELT UNCOMFORTABLE, AND WENT INTO SHOCK. HE COULD NOT BE RESUSCITATED. THE DOCTOR THOUGHT THAT HE MIGHT HAVE BLOCKED OFF THE DOMINANT CX WHEN HE INFLATED THE CLEARWAY.

    Description of Event or Problem · 1

    PATIENT CAME INTO THE CATH LAB WITH AN ANTERIOR MYOCARDIAL INFARCTION. THROMBUS WAS FOUND IN THE PROXIMAL LAD, THERE WAS AN OCCLUSION IN THE MID RCA. AN ASPIRATION CATHETER WAS USED, FOLLOWED BY A PRE-DILATION WITH A 2.5 MM BALLOON. A 2.0 X 20MM CLEARWAY WAS USED TO DELIVER THE REPRO BOLUS. AFTER 10-15 SECONDS, THE PATIENT FELT UNCOMFORTABLE, AND WENT INTO SHOCK. HE COULD NOT BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARWAY RX NONE DXE ATRIUM MEDICAL CORP. 80214

    Patients

    Seq Age Sex Outcome Treatment
    1 Death