BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO PTCA GUIDE WIRE

    MDR report key: 2880056 · Received December 19, 2012

    Report

    Report Number
    3003775027-2012-00065
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K052339
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. EVALUATION SUMMARY: THE CORE WIRE OF THE RETURNED CONFIANZA PRO 12 GUIDE WIRE WAS BROKEN APART APPROXIMATELY 8 MM FROM THE DISTAL END. TRACE OF CLOCKWISE ROTATION FORCE WAS OBSERVED AT THE SECTION ADJACENT TO THE BREAKAGE SITE; HOWEVER, NO BEND OR THE TRACE OF FORCE FROM THE OUTSIDE OF GUIDE WIRE WAS OBSERVED WITH THE GUIDEWIRE DISTAL SECTION. WITH THE OUTCOME OF INSPECTION OF THE RETURNED GUIDE WIRE, IT IS INFERRED THAT THE GUIDE WIRE DISTAL END WAS TRAPPED BY THE CTO LESION, WHERE CLOCKWISE ROTATIONAL MANIPULATION WAS CONSECUTIVELY APPLIED, RESULTING THE BREAKAGE OF THE CORE WIRE WHEN THE ACCUMULATED FORCE EXCEEDED THE PRODUCTS DESIGN LIMIT. WARNING SECTION OF THE INSTRUCTION FOR USE DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE 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 GUIDE WIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED, ... RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL AND SEPARATION OR BREAKAGE OF GUIDE WIRE AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND CALCIFICATION. DURING A RETROGRADE APPROACH, THE CONFIANZA PRO GUIDE WIRE WAS ADVANCED AND ATTEMPTED TO BE SNARED INTO THE GUIDING CATHETER; HOWEVER, THE TIP SEPARATED AND REMAINS IN THE PATIENT ANATOMY. THE PATIENT WAS TREATED SUCCESSFULLY WITH A NEW GUIDE WIRE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CONFIANZA PRO PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 120824A45S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE CATH: CORSAIR