BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GAIA THIRD

    MDR report key: 6144192 · Received December 5, 2016

    Report

    Report Number
    3003775027-2016-00211
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 8, 2016
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K133865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE DETERMINED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. WHEN THE GUIDEWIRE WAS RETURNED FOR THE MANUFACTURER INVESTIGATION, A TIP FRAGMENT OF A MICRO CATHETER THAT WAS USED TOGETHER IN THE PROCEDURE WAS TANGLED WITH THE RETURNED GUIDEWIRE. COILS OF THE GUIDEWIRE WERE NOTED TO BE UNRAVELED ON THE DISTAL SIDE OF THE TANGLED TIP FRAGMENT AND TIGHTENED ON THE PROXIMAL SIDE. PROXIMAL TO THE MIDDLE SOLDER, COILS WERE ALSO UNRAVELED. UNDER X-RAY INVESTIGATION, A PART OF COILS OF THE GUIDEWIRE WAS NOTED TO BE BROKEN. INVESTIGATION OF THE PRODUCTION RECORD COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS AVAILABLE. THOUGH THE DEVICE INVESTIGATION AND LOT HISTORY REVIEW COULD NOT BE CONDUCTED, 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. BASED ON THE OBTAINED INFORMATION AND THE INVESTIGATION OUTCOME OF THE RETURNED DEVICES, IT IS PRESUMED THAT ROTATIONAL EXCEEDING THE PRODUCT'S DESIGN LIMIT MIGHT BE INADVERTENTLY GIVEN WHILE THE GUIDEWIRE AND THE MICRO CATHETER WERE STUCK BY THE LESION. THE ROTATIONAL FORCE WAS THOUGHT TO BE APPLIED CONTINUOUSLY LEADING UNRAVELED COILS TO BREAK UP. WARNINGS SECTION OF IFU STATES THAT: - NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS THE RESISTANCE. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE AND/OR GUIDEWIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. - IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. - WHEN TORQUING THE GUIDEWIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDEWIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDEWIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720?) IN THE SAME DIRECTION. THE MICRO CATHETER USED IN COMBINATION HAS BEEN REPORTED AS 3003775027-2016-00202 ON 11/16/2016.

    Description of Event or Problem · 1

    REPORTEDLY, DURING PCI PROCEDURE FOR MID LAD CTO LESION, THE GUIDEWIRE WAS USED WITH A MICRO CATHETER AND WHEN THE DEVICES REMOVED FROM THE VESSEL IT WAS FOUND THAT THE CATHETER TIP WAS BROKE OFF. THE PHYSICIAN HAD NO COMMENT ON THE GUIDEWIRE; HOWEVER, WHEN THE DEVICES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, IT WAS FOUND THAT A PART OF THE GUIDEWIRE COILS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797247 ASAHI GAIA THIRD PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1