BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GAIA FIRST PRE-SHAPE

    MDR report key: 4801162 · Received May 26, 2015

    Report

    Report Number
    3003775027-2015-00043
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 21, 2015
    Report Date
    May 1, 2015
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K133865
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINGLE REPORTER EXEMPTION #(B)(4). ELONGATED COIL CAPTURED BY THE SNARE ONLY WAS RETURNED HOWEVER THE BROKEN PROXIMAL SECTION PORTION INCLUDING THE GUIDEWIRE SHAFT WAS NOT RETURNED. COIL DISTAL END 25MM WAS FOUND INTACT WITH NO NOTABLE UNRAVEL OR STRETCH. MICROSCOPIC OBSERVATION REVEALED BREAKAGE OF CORE WIRE AT APPROX. 7.5MM FROM TIP END, MEANWHILE NO BREAKAGE WITH THE INNER STRANDED CORE, CLOSE OBSERVATION INDICATED THE TRACE OF CONTINUED ROTATION TO COUNTERCLOCKWISE DIRECTION BEFORE BREAKAGE. LOT HISTORY REVIEW REVEALED NO ANOMALY WITH THIS PRODUCT LOT, NO OTHER SIMILAR EVENT REPORT HAS BEEN RECEIVED. WITH THE OBTAINED INFORMATION AND OUTCOMES OF INVESTIGATION OF RETURNED PARTS, IT IS PRESUMED THE GUIDE WIRE DISTAL END MIGHT BE CAUGHT IN THE CTO LESION AND THE FREE MOVEMENT OF THE DISTAL END WAS RESTRICTED, WHERE ROTATIONAL MANIPULATION MIGHT BE GIVEN TO THE GUIDE WIRE, ROTATIONAL FORCE WAS ACCUMULATED AND EXCEEDED THE PRODUCTS DESIGN LIMIT, RESULTING THE BREAKAGE OF CORE WIRE. ALONG WITH FURTHER MANIPULATION TO THE GUIDEWIRE, THE COIL WAS ELONGATED AND THIS BREAKAGE WAS NOTICED BY THE PHYSICIAN.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE USE OF THE SUBJECT GUIDEWIRE TO CTO LESION AT #4 OF RCA AND ATTEMPTING TO CROSS THE LESION, IT WAS NOTICED THAT THE COIL WIRE ELONGATED IN VESSEL. SNARE WAS ADVANCED INTO THE VESSEL TO RETRIEVE THE GUIDEWIRE, THE GUIDEWIRE COULD BE ENTIRELY REMOVED OUT WITHOUT SEPARATION NOR LEAVING FRAGMENT IN THE ANATOMY. PROCEDURE WAS COMPLETED BY DEPLOYING A STENT, AND REPORTEDLY THE PATIENT WAS DISCHARGED WITH NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339020 ASAHI GAIA FIRST PRE-SHAPE PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA 141226A25A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention