BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO 8-20

    MDR report key: 5700204 · Received June 6, 2016

    Report

    Report Number
    3003775027-2016-00079
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    April 28, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORT IS SOLD ONLY OUTSIDE THE USA, BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY MARKETED DEVICE, ASTATO XS 20 (K103057), THOUGH THE INDICATIONS FOR USE ARE DIFFERENT. THE REPORTED EVENT IS RELATED TO THE USE OF THE GUIDEWIRE IN A CORONARY APPLICATION, WHEREAS THE US MARKETED DEVICE IS CLEARED FOR PERIPHERAL APPLICATIONS ONLY. INSPECTION OF THE GUIDEWIRE REVEALED THE CORE WIRE WAS BROKEN OFF AT APPROX. 5CM FROM TIP END, COIL WIRE WAS ELONGATED BUT NOT SEPARATED UP TO THE DISTAL END, GUIDEWIRE WAS IN ONE UNIT. CLOSE OBSERVATION OF THE BREAKAGE SITE OF THE CORE WIRE REVEALED THE TRACE OF BREAKAGE DUE TO REPEATED BENDING FORCE. LOT HISTORY REVIEW REVEALED NO ANOMALY WITH THIS LOT PRODUCTS. NO OTHER EVENT WAS REPORTED FOR THIS LOT. ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA. BASED ON THE OBTAINED INFORMATION AND THE OUTCOMES OF THE INVESTIGATION, IT IS INFERRED THAT DURING THE ATTEMPT OF BAIL OUT WITH ADDITIONAL DEVICE AND THE ADDITIONAL MANIPULATION TO THE GUIDEWIRE UNDER THE CONDITION WHERE THE TIP WAS TRAPPED IN THE LESION, PUSHING AND BENDING FORCE WAS REPEATEDLY GIVEN TO THE GUIDEWIRE, THE FORCE WAS ACCUMULATED TO THE CORE WIRE, WHICH RESULTED WITH THE BREAKAGE OF CORE WIRE DUE TO THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT, WHILE IT WAS REMOVED IN ONE UNIT WITHOUT SEPARATION. WARNING SECTION OF THE IFU DESCRIBES: IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDEWIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDEWIRE ITSELF. 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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    REPORTEDLY, TO TREAT THE HEAVILY CALCIFIED CTO LESION AT #2 RCA, CROSSING OF OTHER GUIDEWIRE WITH SUPPORT CATHETER WAS ATTEMPTED AND FAILED. THE GUIDEWIRE WAS EXCHANGED TO THE SUBJECT GUIDEWIRE FOR ANOTHER ATTEMPT HOWEVER, TIP OF THIS GUIDEWIRE BECAME STUCK IN THE TARGET LESION DURING THE ATTEMPT. ADDITIONAL GUIDEWIRE AND BALLOON CATHETER WERE ADVANCED BY PARALLEL MANNER; HOWEVER THE ATTEMPT TO RELEASE THE TRAPPED GUIDEWIRE WAS UNSUCCESSFUL. THE SUPPORT CATHETER WAS THEN ADVANCED AS DISTAL AS POSSIBLE OF THE GUIDEWIRE AND THE DEVICES WERE REMOVED OUT TOGETHER. GUIDEWIRE WAS FOUND ITS COIL ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354897 ASAHI CONFIANZA PRO 8-20 PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA 140207A04A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention