BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRAND SLAM GUIDEWIRE

    MDR report key: 4122296 · Received September 18, 2014

    Report

    Report Number
    3003775027-2014-00045
    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
    K022762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE SEPARATED DISTAL PORTION OF THE GUIDEWIRE APPROX. 25MM WAS RETURNED, WHICH WAS ROUNDLY AND HELICALLY BENT. SEM OBSERVATION OF THE BREAKAGE SITE INDICATED THAT THE CORE WIRE WAS BROKEN DUE TO REPEATED BENDING FORCE. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT, NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. WITH THE PROVIDED INFORMATION AND THE OUTCOMES OF THE INVESTIGATIONS, IT IS INFERRED THAT, DURING THE BALLOON CATHETER DELIVERY AND INFLATION OVER THE GUIDEWIRE, THE FORCE TO BACK AND FORWARD MIGHT BE UNINTENTIONALLY GIVEN TO THE GUIDEWIRE WHILE ITS DISTAL AND WAS KEPT IN "J" BEND FORM IN THE VESSEL, SO THAT THE BENDING FORCE MIGHT BE REPEATEDLY WORKED AND ACCUMULATED AT THE BENT POINT, THE GUIDEWIRE WAS BROKEN APART WHEN THE ACCUMULATED FORCE EXCEEDED THE PRODUCT'S DESIGN LIMIT.

    Description of Event or Problem · 1

    THE DATE THE DISTRIBUTOR BECOMES AWARE IS QUOTED AS THE DATE OF THE EVENT AS IT IS NOT AVAILABLE. REPORTEDLY, PCI TO PROXIMAL LAD/DIAGONAL BRANCH, A GUIDEWIRE WAS ADVANCED TO DIAGONAL BRANCH AND EXCHANGED TO THE SUBJECT GUIDEWIRE THROUGH AN OTW BALLOON CATHETER WITH NO TROUBLE. THE GUIDEWIRE WAS LAID STABLE IN THE DIAGONAL BRANCH IN A J LOOP FASHION. THE STENOSIS IN THE PROX LAD/PROX DIAGONAL BRANCH WAS DILATED WITH THE BALLOON CATHETER. AFTER DILATATION PERFORMED OVER THE GUIDEWIRE, IT WAS NOTICED THAT THE DISTAL TIP OF THE GUIDEWIRE WAS DETACHED. THE FRAGMENT WAS RETRIEVED OUT BY USING ADDITIONAL GUIDEWIRE TO TRAP. PATIENT WAS FINALLY DISCHARGED, THOUGH VESSEL PERFORATION WAS NOTICED AND TREATED DURING THE RETRIEVAL PROCESS. THE PERFORATION WILL BE SEPARATELY REPORTED UNDER 3003775027-2014-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579409 ASAHI GRAND SLAM GUIDEWIRE PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA A130710A25A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention