BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONFIANZA PRO 8-20

    MDR report key: 5899075 · Received August 23, 2016

    Report

    Report Number
    3003775027-2016-00144
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    July 27, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORT IS SOLD ONLY OUTSIDE THE USA, BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION TO A DEVICE CURRENTLY MARKETED IN USA; 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. INVESTIGATION OF THE GUIDEWIRE RETURNED ON 8/08 REVEALED ITS COIL WIRE IS DAMAGED AT TIP BRAZING BUT THERE WAS NO SEPARATION WITH IT, THE GUIDEWIRE WAS ENTIRE. THE MICROCATHETER USED IN COMBINATION WAS ALSO RETURNED, WHICH SHOWED NO NOTABLE DAMAGE. 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 THE TIP MIGHT BE TRAPPED IN THE CTO LESION AND ROTATIONAL MANIPULATION WAS APPLIED TO THE GUIDEWIRE, RESULTING THE ACCUMULATION OF ROTATIONAL FORCE TO COIL AND BREAKAGE AT THE DISTAL TIP BRAZING. 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.

    Description of Event or Problem · 1

    REPORTEDLY, TO TREAT THE HEAVILY TORTUOUS HEAVILY CALCIFIED CTO LESION AT #2 RCA, SUBJECT GUIDEWIRE WAS ADVANCED WITH A SUPPORT CATHETER. DURING THE ATTEMPTS TO CROSS THE TARGET LESION, PHYSICIAN FELT SOME IRREGULAR WITH THE GUIDEWIRE, AND UPON REMOVAL, DAMAGE WAS FOUND AT THE TIP OF THE GUIDEWIRE. THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550434 ASAHI CONFIANZA PRO 8-20 PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA 141119A74A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR