BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASAHI FIELDER XT PTCA GUIDE WIRE

    MDR report key: 4606675 · Received March 16, 2015

    Report

    Report Number
    3003775027-2015-00026
    Event Type
    Death
    Date Received
    March 16, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K072431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: WITH THE PROVIDED INFORMATION, WE COULD NOT IDENTIFY WHETHER OR NOT THERE WAS ANY TROUBLE WITH THE GUIDEWIRE, THE CAUSE OF AND THE CAUSALITY OF SUBJECT GUIDEWIRE WITH THE REPORTED EVENT. SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE FIELDER XT INSTRUCTIONS FOR USE (IFU) DESCRIBES: THERE ARE PATIENT RISKS WHEN USING ANY GUIDE WIRE, POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDE WIRE USE INCLUDE, BUT ARE NOT LIMITED TO: CORONARY ARTERY THROMBUS. THE WHISPER AND THE TWO PILOT GUIDE WIRES REFERENCED, ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 GUIDE WIRES WERE USED CONSECUTIVELY, ONE RIGHT AFTER THE OTHER, IN AN ATTEMPT TO BREAK THROUGH A TOTALLY OCCLUDED, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. THE FOUR GUIDE WIRES INCLUDED A WHISPER, TWO PILOT AND A FIELDER XT. DURING USE OF THE DEVICES, IT WAS NOTED THAT THE ENTIRE CIRCUMFLEX CORONARY ARTERY AND LAD BECAME OCCLUDED WITH THROMBUS. PART OF THE THROMBUS TRAVELED TO THE CEREBRAL VASCULATURE, RESULTING IN A CEREBRAL VASCULAR ACCIDENT (CVA) AND DEATH. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178332 ASAHI FIELDER XT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death GUIDE WIRES: PILOT (2), WHISPER