BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGALIA XS 1.0

    MDR report key: 16971094 · Received May 21, 2023

    Report

    Report Number
    3003775027-2023-00053
    Event Type
    Injury
    Date Received
    May 21, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131094
    PMA / PMN Number
    K163426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: TOYOFLEX CEBU CORPORATION, CEBU, PHILIPPINES, REGISTRATION NUMBER: NA; THIS MANUFACTURING SITE IS NOT FDA REGISTERED AND DEVICES PRODUCED BY IT ARE NOT DISTRIBUTED OR SOLD IN THE US. WHEN THE REPORTED PRODUCT WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, G3. DATE RECEIVED BY MANUFACTURER IS THE SAME AS THE DATE IN D9. RETURNED TO MANUFACTURER. THE REPORTED REGALIA XS 1.0 GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE CONCOMITANT CORSAIR ARMET MICROCATHETER. THE RETURNED REGALIA XS 1.0 GUIDE WIRE WAS FOUND BENT AT APPROXIMATELY 15MM-25MM FROM THE TIP. AT APPROXIMATELY 20MM FROM THE TIP, THE POLYMER JACKET WAS FOUND TORN OFF. THE POLYMER JACKET WAS PEELED FOR APPROXIMATELY 5MM PROXIMAL TO THE TORN END. THE PEELED POLYMER JACKET GATHERED PROXIMALLY, EXPOSING THE UNDERLYING COIL. DISTAL TO THE TORN END OF THE POLYMER JACKET, THE POLYMER JACKET WAS FOUND TWISTED AND STRETCHED. A TRACE OF DUCTILE TEARING WAS CONFIRMED AT THE TORN END. THE BALL TIP WAS FOUND ATTACHED ON THE VERY DISTAL END OF THE REGALIA XS 1.0 GUIDE WIRE, SUGGESTING THAT THE COIL WAS NOT FRACTURED. THE CONCOMITANT CORSAIR ARMET MICROCATHETER WAS FOUND WITH NO DAMAGE SUCH AS KINK WHICH COULD BE RELATED TO THE REPORTED CASE THROUGHOUT THE LENGTH. 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE POLYMER JACKET OF THE REGALIA XS 1.0 GUIDE WIRE WAS STRETCHED AND TORN BY STRONG FRICTION LIKELY WITH THE CTO DURING PUSHING AND PULLING MANIPULATION. CONTINUED PUSHING AND PULLING MANIPULATION THEN MADE THE POLYMER JACKET BECOME PEELED, INCREASING THE RESISTANCE WITH THE CONCOMITANT CORSAIR ARMET MICROCATHETER. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY OF RETENTION OF POLYMER JACKET FRAGMENTS. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] 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. IF RESISTANCE IS FELT BETWEEN THIS GUIDE WIRE AND THE OTHER INTERVENTIONAL DEVICES WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL, AVOID APPLYING EXCESSIVE FORCE. WHEN ABNORMAL RESISTANCE IS FELT, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S BODY AND DETERMINE THE CAUSE. OTHERWISE, THE GUIDE WIRE MAY BREAK OR BE DAMAGED AND MAY CAUSE INJURY TO THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS]. ABRASION OF THE GUIDE WIRE COATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY. WHEN AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS USED WITH AN ASAHI CORSAIR ARMET MICROCATHETER, RESISTANCE WAS FELT DURING THE PROCEDURE. AFTER CONTINUED MANIPULATION, THE TWO DEVICES BECAME STUCK TO EACH OTHER. NO ADDITIONAL ACTION WAS TAKEN AGAINST THIS EVENT. THE MICROCATHETER AND THE GUIDE WIRE WERE THEN REPLACED TO RESUME THE PROCEDURE. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478302 REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 230119A06F 04547327131094

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other