BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER XT

    MDR report key: 17302943 · Received July 11, 2023

    Report

    Report Number
    3003775027-2023-00067
    Event Type
    Injury
    Date Received
    July 11, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327112017
    PMA / PMN Number
    K171933
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. THE REPORTED FIELDER XT GUIDE WIRE WAS RETURNED FOR EVALUATION. ORIGINATING FROM APPROXIMATELY 135MM DISTAL TO THE PROXIMAL SOLDER (SET AT 160MM FROM THE TIP FOR THE PURPOSE OF FIXING THE COIL ONTO THE CORE), ELONGATED COIL WAS EXPOSED FOR APPROXIMATELY 55MM. THE CORE WAS FOUND FRACTURED AT APPROXIMATELY 155MM DISTAL TO THE PROXIMAL SOLDER. AT APPROXIMATELY 210MM DISTAL TO THE PROXIMAL SOLDER, THE COIL WAS FRACTURED. OBSERVATION OF THE CORE FRACTURE END BY MICROSCOPE AND SCANNING ELECTRON MICROSCOPE FOUND THAT THE CORE WAS CUT LIKELY BY A SHARP BLADE. THE POLYMER JACKET WAS REMOVED FOR OBSERVATION OF THE COIL FRACTURE END. THE COIL FRACTURE END ALSO HAD A CUT SURFACE. MEASUREMENT OF THE RETURNED GUIDE WIRE AND THE OBSERVED CHARACTERISTIC OF THE FRACTURE ENDS SUGGESTED THAT THE WIRE TIP WAS INTENTIONALLY CUT AT APPROXIMATELY 5MM FROM THE TIP. 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 PROVIDED INFORMATION AND THE ABOVE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE TIP OF THE FIELDER XT GUIDE WIRE WAS INTENTIONALLY CUT PROBABLY BY A CUTTING BALLOON TO RELEASE THE STUCK GUIDE WIRE FROM THE HEAVILY CALCIFIED CTO. THE FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE COIL ELONGATE ALONG WITH TEARING OF THE POLYMER JACKET ON THE PROXIMAL SIDE OF THE CUT. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. GIVEN THAT THE CUT TIP OF THE FIELDER XT GUIDE WIRE WAS NOT RETURNED, A POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT IT MIGHT BE LEFT IN THE PATIENT. NO CAPA WILL BE TAKEN. 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. IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. 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, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS] REMOVAL DIFFICULTY OF GUIDE WIRE. SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN ATTEMPTING TO CROSS THE LESION WITH AN ASAHI FIELDER XT GUIDE WIRE, THE GUIDE WIRE BECAME STUCK IN THE LESION. WHEN REMOVING THE STUCK FIELDER XT GUIDE WIRE, RESISTANCE WAS FELT AND THE GUIDE WIRE BECAME DAMAGED. AFTER REMOVAL, THE POLYMER JACKET OF THE FIELDER XT GUIDE WIRE WAS FOUND TORN AND THE COIL WAS STRETCHED, EXPOSING THE CORE. THERE WAS NO IMPACT TO THE PATIENT DUE TO THIS EVENT AND THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803434 FIELDER XT PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 221212A30A 04547327112017

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other