BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGALIA XS 1.0

    MDR report key: 19266055 · Received May 8, 2024

    Report

    Report Number
    3003775027-2024-00052
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    March 13, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131107
    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: 3016119728 THE REPORTED REGALIA XS 1.0 GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE CORE WIRE AND POLYMER JACKET OF THE RETURNED REGALIA XS 1.0 GUIDE WIRE WAS FOUND TORN AT APPROXIMATELY 93MM DISTAL TO THE PROXIMAL SOLDER (SET AT 120MM FROM THE TIP TO FIX THE OUTER COIL ONTO THE CORE WIRE). THE ELONGATED AND FRACTURED OUTER COIL WAS EXPOSED FOR APPROXIMATELY 17MM. THE FRACTURE END OF THE OUTER COIL WAS FOUND NECKED, INDICATING THAT THE FRACTURE WAS CAUSED BY TENSIONAL STRESS. MICROSCOPIC OBSERVATION OF THE FRACTURE END OF THE POLYMER JACKET FOUND TRACES OF DUCTILE FRACTURE CAUSED BY ELONGATION. FROM THE ELONGATED POLYMER JACKET, THE CURVED CORE WIRE WAS FOUND COMING OUT AND FRACTURED. THE FRAGMENT OF THE REGALIA XS 1.0 GUIDE WIRE WAS REMOVED FROM THE SNARE FOR OBSERVATION. THE GUIDE WIRE FRAGMENT WAS APPROXIMATELY 50MM IN LENGTH AND ITS DISTAL SEGMENT WAS FOUND CORRUGATED. FROM THE TORN END OF THE POLYMER JACKET, THE ELONGATED OUTER COIL WITH A NECKED FRACTURE END WAS COMING OUT, JUST AS THE PROXIMAL SIDE OF THE GUIDE WIRE. THE TORN END OF THE POLYMER JACKED HAD TRACES OF DUCTILE FRACTURE. AT THE TIP OF THE FRAGMENT, A BALL TIP WAS FOUND. TO OBSERVE THE CORE WIRE FRACTURE END OF THE FRAGMENT, THE POLYMER JACKET WAS REMOVED. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 27MM FROM THE TIP. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT BOTH FRACTURE ENDS OF THE CORE WIRE HAD UNEVEN FRACTURE SURFACES AND CIRCUMFERENTIAL CRACKS ON THE WIRE SHAFTS WHICH COULD BE ATTRIBUTED TO REPEATED PRESSING AND BENDING. MEASUREMENT OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 27MM PROXIMAL TO THE DISTAL MID SOLDER (SET AT 25MM FROM THE TIP), THE OUTER COIL AND THE POLYMER JACKET WERE STRETCHED AND TORN, AND THE DISTAL SEGMENT WAS DETACHED. 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT REPEATED PUSHING AND BENDING STRESS MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE CORE WIRE DUE TO PUSHING AND PULLING WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE REGALIA XS 1.0 HAD BEEN CAUGHT IN THE LESION, FRACTURING THE CORE WIRE. AS TENSIONAL STRESS WAS APPLIED DURING WITHDRAWAL, THE OUTER COIL TOGETHER WITH THE POLYMER JACKET WAS STRETCHED AND TORN OFF. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. HOWEVER, ADDITIONAL TREATMENT WITH SNARE IS CONSIDERED AS A HEALTH HAZARD, AND IT WAS CONCLUDED THAT POSSIBILITY OF FRAGMENT BEING LEFT IN THE PATIENT ANATOMY COULD NOT BE COMPLETELY RULED OUT IF THE REPORTED EVENT RECURS. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A 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 GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING WIRE MANIPULATIONS. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE TIP. IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION.[OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR.] DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. 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 GUIDE WIRE. 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. [MALFUNCTIONS AND ADVERSE EFFECTS]. SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI REGALIA XS 1.0 GUIDE WIRE WAS USED TO TREAT A MODERATELY CALCIFIED, 90-99% OCCLUDED LESION IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). AS THE REGALIA XS 1.0 GUIDE WIRE GOT STUCK IN THE LESION AND FRACTURED, AN UNSPECIFIED SNARE WAS USED TO REMOVE THE DETACHED DISTAL SEGMENT. THE GUIDE WIRE WAS REPLACED BY AN UNSPECIFIED GUIDE WIRE, AND THE PROCEDURE WAS CONTINUED. EVENTUALLY, A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH REESTABLISHED BLOOD FLOW. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE EVENT AND THERE WERE NO ISSUES WITH THE PATIENT AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811266 REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. 231005A12F 04547327131107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O