BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION BLUE

    MDR report key: 20519271 · Received October 23, 2024

    Report

    Report Number
    3003775027-2024-00112
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327098151
    PMA / PMN Number
    K163426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED. PHOTO IMAGES OF THE SUBJECT SION BLUE WERE PROVIDED. WHEN EXAMINED, THE DISTAL SEGMENT OF THE SUBJECT SION BLUE WAS FOUND WITH ITS COIL PITCH WIDENED LIKELY CAUSED BY TENSION. HOWEVER, PRESENCE OR ABSENCE OF THE BALL COULD NOT BE CONFIRMED. IN ADDITION, THE DETACHED SEGMENT AND ITS LENGTH COULD NOT BE IDENTIFIED FROM THE INVESTIGATION. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND THE WIDENED COIL PITCH SHOWN IN THE PROVIDED PHOTO IMAGES, IT WAS PRESUMED THAT EXCESSIVE TENSION GENERATED WITH GUIDE WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE SUBJECT SION BLUE WAS CAUGHT IN THE LESION MIGHT HAVE BEEN LOCALLY APPLIED ON THE DISTAL SEGMENT OF THE GUIDE WIRE, CAUSING THE SEGMENT TO BE FRACTURED. CONSEQUENTLY, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS FRACTURED AND LEFT IN THE PATIENT ANATOMY. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTE TO THE PRODUCT QUALITY, THE WIRE FRAGMENT LEFT IN SITU WAS CONSIDERED A PERMANENT IMPAIRMENT AND THEREFORE A HEALTH HAZARD. NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. ~ WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A BIFURCATION LESION WITH ITS 80%-OCCLUDED DISTAL SEGMENT IN AN UNSPECIFIED CORONARY ARTERY OF A PATIENT PRESENTING UNSTABLE ANGINA. ALTHOUGH NO RESISTANCE WAS FELT DURING GUIDE WIRE MANIPULATION AND WITHDRAWAL, THE SUBJECT SION BLUE GUIDE WIRE WAS FRACTURED AND ITS FRAGMENT OF APPROXIMATELY 3MM IN LENGTH WAS LEFT IN THE LESION IN THE DISTAL DIAGONAL BRANCH. IT WAS INFORMED THAT THE PHYSICIAN DECIDED TO LEAVE THE FRAGMENT IN SITU AND THE PATIENT WAS PUT UNDER OBSERVATION. IT WAS ALSO INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS OR ADDITIONAL TREATMENTS PROVIDED TO THE PATIENT, WHO WAS ALREADY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571227 ASAHI SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AHW14R004S 240327A08A 04547327098151

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Disability