BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 23754302 · Received December 9, 2025

    Report

    Report Number
    3012223769-2025-00003
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 9, 2025
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690023
    PMA / PMN Number
    K203529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THIS EVENT OCCURRED IN JAPAN AND NOT IN THE UNITED STATES, SIMILAR PRODUCTS (PRODUCT FAMILY) ARE DISTRIBUTED IN THE U.S., SO AN MDR WILL BE CONDUCTED. MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). [MANUFACTURING RECORDS] ALL PRODUCTS WERE CONFIRMED TO HAVE PASSED INSPECTION. [LOT HISTORY REVIEW] NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. [COMPLAINT HISTORY REVIEW] COMPLAINTS ABOUT PRODUCTS OF THE SAME STRUCTURE (VGW1423NS1, VGW1430NS1, VGW1423NS3, VGW1430NS3, 014IN HYBRID L 190CM, 014IN HYBRID L 300CM, 018IN SS HYBRID L 190CM, 018IN SS HYBRID L 300CM) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF POLYMER JACKET PEELING WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] AN INVESTIGATION OF THE RETURNED PRODUCT REVEALED THE FOLLOWING: THE PRODUCT HAD THE REAR END OF THE PLASTIC JACKET, APPROXIMATELY 570 MM FROM THE TIP, DETACHED FROM THE CORE WIRE, WITH ABOUT 10 MM COMPRESSED TOWARD THE TIP. FURTHERMORE, WITHIN APPROXIMATELY 40 MM BEFORE AND AFTER THE DETACHED AREA, THE CORE WIRE WAS KINKED IN SEVERAL PLACES, AND ONE LOCATION EXHIBITED SIGNIFICANT TWISTING. IN ADDITION, A TEAR WAS OBSERVED IN PART OF THE PLASTIC JACKET AT THE TWISTED SECTION OF THE CORE WIRE, AND THERE WERE ALSO ABRASION MARKS AND DAMAGE ON THE PLASTIC JACKET DISTAL TO THAT LOCATION. FURTHERMORE, PEELING, LIKELY CAUSED BY CONTACT WITH A SHARP OBJECT, WAS FOUND ON THE PROXIMAL PTFE-COATED SECTION. EXTENSIVE SCRATCHES WERE OBSERVED ON THE PLASTIC JACKET AND PTFE COATING OF THE PRODUCT, CAUSED BY CONTACT WITH A HARD, SHARP OBJECT. THESE SCRATCHES RESEMBLE THOSE THAT OCCUR WHEN THE PRODUCT IS MOVED WITHOUT SUFFICIENTLY LOOSENING THE TORQUE DEVICE. THEREFORE, IT IS CONSIDERED THAT THE DAMAGE OCCURRED BECAUSE THE TORQUE DEVICE USED WHEN PASSING THE PRODUCT THROUGH THE LESION WAS NOT SUFFICIENTLY LOOSENED DURING ATTACHMENT, DETACHMENT, OR MOVEMENT. ADDITIONALLY, REGARDING THE DETACHMENT APPROXIMATELY 570 MM FROM THE TIP, THERE IS A POSSIBILITY THAT THE TORQUE DEVICE WAS ATTACHED NEAR THIS AREA DURING WIRING INTO THE LESION. EXCESSIVE CONTACT AT THAT TIME MAY HAVE CAUSED DAMAGE, AND RESISTANCE WITH THE IVUS USED IN COMBINATION MAY HAVE LED TO THE DETACHMENT. BASED ON THE MANUFACTURING HISTORY AND INSPECTION RECORDS, AS WELL AS THE ABOVE INVESTIGATION RESULTS, IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS NOT CAUSED BY PRODUCT QUALITY. HOWEVER, IT CANNOT BE SAID THAT THERE IS NO POSSIBILITY OF SERIOUS HEALTH HAZARD IN THE EVENT OF RECURRENCE OF THE SIMILAR EVENT, AND THE POSSIBILITY OF THE DETACHED FRAGMENTS REMAINING IN THE PATIENT'S BODY CANNOT BE COMPLETELY RULED OUT. INSTRUCTIONS FOR USE (IFU) STATES BELOW AND NO CAPA WILL BE TAKEN. [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. ~DO NOT PUSH THE GUIDE WIRE MORE THAN NECESSARY TO ADVANCE THE TIP THROUGH THE NARROWED PART OF THE VESSEL. (FOR EXAMPLE, DO NOT PUSH THE GUIDE WIRE WHEN THE DISTAL TIP OF THE GUIDE WIRE IS BENT BY THE FORCE OF MANIPULATION.) AFTER CROSSING THE TARGETED AREA, DO NOT ROUGHLY TWIST, PUSH OR PULL THE GUIDE WIRE. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BE DAMAGED OR BREAK APART, WHICH MAY INJURE THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [HOW TO USE] 3. PROCEDURES FOR INSERTION. ~OVER THE WIRE SYSTEM G) INSERT THE TORQUE DEVICE FROM THE PROXIMAL END OF THE GUIDEWIRE IF NECESSARY AND MANIPULATE THE GUIDEWIRE VIA THE TORQUE DEVICE. WHEN REPOSITIONING THE TORQUE DEVICE OVER THE GUIDEWIRE, ENSURE THAT THE TORQUE DEVICE IS RELEASED COMPLETELY FROM THE GUIDEWIRE PRIOR TO REPOSITIONING. DO NOT ATTACH THE TORQUE DEVICE OVER THE HYDROPHILIC COATING. [MALFUNCTION AND ADVERSE EFFECTS] POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDE WIRE USE INCLUDE, BUT ARE NOT LIMITED TO: DAMAGE OF GUIDEWIRE (SEPARATION, BREAKAGE, DAMAGE OF COATING).

    Description of Event or Problem · 0

    FOR A NON-CALCIFIED SFA LESION WITH A STENOSIS RATE OF 70-100%, AFTER PASSING THE LESION WITH THE PRODUCT (VGW1430NS3), AN IVUS CATHETER (HEREINAFTER REFERRED TO AS IVUS) WAS ADVANCED. HOWEVER, THE IVUS BECAME STUCK PARTWAY THROUGH THE PRODUCT AND COULD NOT BE ADVANCED ANY FURTHER. THE PHYSICIAN SUSPECTED AN ISSUE WITH THE IVUS ITSELF AND REPLACED IT WITH ANOTHER IVUS BUT WAS UNABLE TO ADVANCE IT PAST THE SAME LOCATION. UPON REMOVING THE PRODUCT FROM THE BODY, IT WAS FOUND THAT THE PLASTIC JACKET HAD PEELED OFF FOR SEVERAL CENTIMETERS AND WAS IN A CRUMPLED STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113810 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. VGW1430NS3 250219R031 04562102690023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other