BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 24975376 · Received April 24, 2026

    Report

    Report Number
    3012223769-2026-00001
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 14, 2026
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04582105830028
    PMA / PMN Number
    K203533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. [MANUFACTURING RECORDS] ALL PRODUCTS WERE CONFIRMED TO HAVE PASSED INSPECTION. [LOT HISTORY REVIEW] ONE SIMILAR DEFECT REPORT HAD BEEN RECEIVED FOR THIS LOT. (3012223769-2026-00002). [COMPLAINT HISTORY REVIEW] COMPLAINTS ABOUT PRODUCTS OF THE SAME STRUCTURE (014IN SS FLOPPY L190CM, 014IN SS FLOPPY L300CM, 018IN SS FLOPPY L 190CM, 018IN SS FLOPPY L 300CM, VGW1423FL0, VGW1430FL0, VGW1423FL0F, VGW1430FL0F, VGT1823FL0, VGT1830FL0, VGT1823FL0F, VGT1830FL0F) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF SEPARATION WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION]SINCE THE PRODUCT WAS NOT RETURNED FROM THE USER FACILITY TO FILMECC YET, THE PRODUCT WAS NOT INVESTIGATED. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~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. [MALFUNCTION AND ADVERSE EFFECTS] POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDE WIRE USE INCLUDE, BUT ARE NOT LIMITED TO: DAMAGE OF GUIDEWIRE (SEPARATION, BREAKAGE) AFTER RECEIVING THE RETURNING PRODUCT, WE WILL MAKE ANOTHER INVESTIGATION AND SUBMIT FOLLOW-UP REPORT ON THE INVESTIGATION RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VASSALLO GT .014 FLOPPY ("THE PRODUCT") WAS CAUGHT UP IN A TERUMO PROGREAT MICROCATHETER AND SHEARED OFF DURING A GENICULAR ARTERY EMBOLIZATION (GAE) PROCEDURE PERFORMED TO TREAT KNEE PAIN. THE VESSELS WERE NON-STENOTIC. BECAUSE THE GUIDEWIRE WAS DAMAGED DURING USE, THE PHYSICIAN REFRAINED FROM USING THIS GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443860 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. 250924R011 04582105830028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other