BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION GUIDEWIRE

    MDR report key: 4122311 · Received September 18, 2014

    Report

    Report Number
    3003775027-2014-00046
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K100578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION COULD NOT BE CONDUCTED SINCE IT WAS NOT RETURNED TO THE MANUFACTURER. LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT INFORMATION WAS AVAILABLE. HOWEVER, SINCE ALL THE GUIDEWIRES ARE INSPECTED DURING THE PRODUCTION PROCESS FOR MEETING THE PRODUCT'S SPECIFICATIONS AND SHIPPING CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. WITH THE PROVIDED INFORMATION, IT IS INFERRED THAT DURING THE ATTEMPT TO REMOVE THE BROKEN FRAGMENTS IN DIAGONAL VESSEL, THE SION GUIDEWIRE MIGHT BE UNINTENTIONALLY ADVANCED INTO THE DISTAL OF THE VESSEL, WHICH MIGHT LEAD THE PERFORATION AT THE DISTAL OF THE DIAGONAL BRANCH.

    Description of Event or Problem · 1

    THE DATE THE DISTRIBUTOR BECAME AWARE IS QUOTED AS THE DATE OF THE EVENT AS IT IS NOT AVAILABLE. REPORTEDLY, PCI TO PROXIMAL LAD/DIAGONAL BRANCH, A STENT DELIVERY WAS PERFORMED OVER THE ASAHI GRAND SLAM GUIDEWIRE OF WHICH DISTAL END WAS LAID STABLE IN THE DIAGONAL BRANCH IN A J LOOP FASHION. AFTER THE STENOSIS IN THE PROX LAD/PROX DIAGONAL BRANCH WAS DILATED WITH THE BALLOON CATHETER, GUIDEWIRE BREAKAGE WAS NOTICED. THEN THE SION GUIDEWIRE WAS ADVANCED INTO THE DIAGONAL TO RETRIEVE THE BROKEN FRAGMENT. DURING THIS PROCEDURE A DISTAL PERFORATION OF THE DIAGONAL BRANCH OCCURRED. THE PERFORATION COULD BE TREATED BY FAT EMBOLIZATION OF THE DISTAL PART OF THE DIAGONAL BRANCH. THE PROCEDURE TARGET LESION WAS TREATED BY STENT. THE BREAKAGE OF GRAND SLAM WILL BE SEPARATELY REPORTED UNDER 3003775027-2014-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579196 ASAHI SION GUIDEWIRE PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention