BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI MIRACLEBROS PTCA GUIDE WIRE

    MDR report key: 1012673 · Received March 12, 2008

    Report

    Report Number
    3003775027-2008-00003
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES, ASAHI INTECC CO.LTD. MEDICAL DIV.
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANTONIO COLOMBO, MD.; TITLED "CTO RECANALIZATION BY INTRAOCCLUSION INJECTION OF CONTRACT. THE MICROCHANNEL TECHNIQUE"; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2008 VOLUME 71:20-26.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: MI/DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED ON 32 PATIENTS WITH CHRONIC TOTAL OCCLUSIONS (CTO). RECANALIZATION BY INTRAOCCLUSION INJECTIONS OF CONTRAST WITHIN THE MICROCHANNEL. THE MICROCHANNEL ONCE VISIBLE HAVE BEEN CONSIDERED IMPORTANT CONDUITS FOR CTO CROSSING, UTILIZING DEDICATED GUIDE WIRES. THE ARTICLE REPORTED ONE MYOCARDIAL INFARCTION, AND 12 DISSECTIONS. THESE EVENTS WILL BE CONSERVATIVELY FILED AS THE MAJORITY OF THE GUIDE WIRES USED WERE ABBOTT CTO GUIDE WIRES. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI MIRACLEBROS PTCA GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES, ASAHI INTECC CO.LTD. MEDICAL DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention GUIDE WIRE: UNKNOWN FLOPPY GUIDE WIRE