BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI CONFIANZA PRO 12 GUIDEWIRE

    MDR report key: 2992471 · Received March 4, 2013

    Report

    Report Number
    3003775027-2013-00010
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ASAHI INTECC CO. , LTD.
    Product Code
    DQX
    PMA / PMN Number
    K052339
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COIL WIRE OF THE GUIDEWIRE WAS BROKEN AT APPROX. 2MM FROM TIP END, WHILE CORE WIRE WAS CONFIRMED ENTIRE UP TO THE PRODUCT TIP END, NOT SEPARATED. SLIGHT ROUND BEND AND COIL STRETCH WAS OBSERVED AT THE DISTAL SECTION OF RETURNED GUIDEWIRE. TRACE OF TORSION AND SEPARATION BY PULL-APART FORCE WAS OBSERVED ON THE COIL WIRE BREAKAGE SITE. LOT HISTORY REVIEW REVEALED THE GUIDEWIRE WAS INSPECTED MEETING THE SHIPPING CRITERIA DURING THE PRODUCTION PROCESS. GUIDEWIRE IS CONSIDERED BEING FREE OF DEFECT. IT IS PRESUMED THAT THE GUIDEWIRE WAS PULLED BACK WITH EXCESSIVE FORCE AGAINST ITS DISTAL END BEING TRAPPED BY THE LESION, RESULTING STRETCH AND BREAKAGE OF COIL WIRE, MEANWHILE THE CORE WIRE WAS REMOVED WITHOUT BREAKAGE DAMAGE. WARNING SECTION OF IFU DESCRIBES; "BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A GUIDEWIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDEWIRE MAY BE DAMAGED." "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, ... RESULTING FRAGMENTS BEING LEFT INSIDE THE VESSEL."

    Description of Event or Problem · 1

    DURING THE TREATMENT TO A HEAVILY CALCIFIED CTO LESION AT SFA, WHEN PHYSICIAN ATTEMPTED TO CROSS THE LESION, THE GUIDEWIRE DISTAL END WAS CAUGHT BY THE CALCIFIED LESION, AND IT WAS NOTICED THAT THE COIL DISTAL END IS BROKEN APART. SEPARATED COIL WAS FIXED TO THE VESSEL WALL BY DEPLOYING A STENT. PT IS GOING WELL AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91524 ASAHI CONFIANZA PRO 12 GUIDEWIRE DQX ASAHI INTECC CO. , LTD. NA 120831A07A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability