BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18108924 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00013
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    November 8, 2021
    Report Date
    November 10, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690023
    PMA / PMN Number
    K203529NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FILMECC IS CONDUCTING A RETROSPECTIVE REVIEW OF WORLD-WIDE COMPLAINTS RECEIVED AFTER 510(K) CLEARANCE BUT PRIOR TO COMMERCIAL RELEASE IN THE UNITED STATES. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. 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] NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. [COMPLAINT HISTORY REVIEW] COMPLAINTS ABOUT PRODUCTS OF THE SAME STRUCTURE ((B)(4)) 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] STRAIGHT LINE OF PRESSURE MARKS AND WRINKLES DUE TO PRESSURE WERE OBSERVED ON THE POLYMER JACKET IN THE RANGE OF APPROXIMATELY 555 MM TO 563 MM FROM THE TIP OF THE PRODUCT. THE CORE WIRE WAS EXPOSED IN THE RANGE OF APPROXIMATELY 567 MM TO 580 MM AND THE RANGE OF APPROXIMATELY 585 MM TO 590 MM FROM THE TIP, AND THE POLYMER JACKET WAS ROLLED UP AND GATHERED INTO A BELLOWS SHAPE. THE POLYMER JACKET WAS RETURNED TO ITS ORIGINAL STATE IN THE AREA WHERE THE POLYMER JACKET HAD BEEN GATHERED INTO A BELLOWS SHAPE AND OBSERVED UNDER MAGNIFICATION, AND IT WAS CONFIRMED THAT THE POLYMER JACKET WAS TORN. BASED ON THE CONDITION OF THE PRODUT AND INFORMATION OBTAINED, IT WAS PRESUMED THAT THE DAMAGES AND PEELING OF THE POLYMER JACKET MAY HAVE BEEN CAUSED BY THE COMBINED DEVICE BEING ADVANCED ALONG THE PRODUCT, WHICH RESULTED IN THE DEVICE TIP EDGE AND OTHER VERY HARD OBJECTS COMING INTO STRONG CONTACT WITH THE SURFACE OF THE PRODUCT, ESPECIALLY AT THE AORTA-ILIAC BIFURCATION WHERE THE ANGLE WAS TIGHT, AND EXCESSIVE LOADING MAY HAVE CAUSED WRINKLES, PRESSURE MARKS AND OTHER DAMAGES. FURTHERMORE, IT WAS PRESUMED THAT THE IVUS TIP WAS ULTIMATELY CAUGHT ON THE DAMAGED AREA DUE TO A PARTIAL TEAR OF THE TIP, AND WAS PULLED IN WHILE DETACHED IN A BELLOWS SHAPE, RESULTING IN RESISTANCE WITH THE PRODUCT AND THE COMBINED DEVICE. AS A RESULT OF ABOVE INVESTIGATION, ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO PRODUCT QUALITY BUT TO THE PROCEDURE, WE CANNOT COMPLETELY RULE OUT THE POSSIBILITY THAT DETACHED PIECES WERE LEFT BEHIND IN THE PATIENT'S BODY. INSTRUCTIONS FOR USE (IFU) STATES BELOW AND NO CAPA WILL BE TAKEN. [WARNINGS] ~DO NOT USE THE GUIDE WIRE IN COMBINATION WITH CATHETERS (ATHERECTOMY CATHETER, METALLIC DILATOR ETC.) WHICH METALLIC PART MAY CONTACT SURFACE OF THIS GUIDE WIRE. [MANIPULATION, ADVANCEMENT, AND/OR WITHDRAWAL THROUGH A METAL DEVICE MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER COATING, RESULTING IN COATING MATERIAL REMAINING IN THE VASCULATURE, WHICH MAY RESULT IN UNINTENDED ADVERSE EVENTS REQUIRING ADDITIONAL INTERVENTION.] ~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. [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

    IT WAS REPORTED THAT VASSALLO GT .014 NS3 (THE PRODUCT) WAS USED IN A CASE OF AN IN-STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY WITH 100% OCCLUSION. AFTER CROSSING THE LESION WITH A NON-FILMECC GUIDEWIRE THROUGH RIGHT FEMORAL APPROACH, THE GUIDEWIRE WAS REPLACED WITH THE PRODUCT. A BALLOON CATHETER, A DRUG-COATED BALLOON CATHETER, AND AN IVUS CATHETER WERE USED AFTER ASPIRATING THROMBUS WITH AN EMBOLIZATION CATHETER, RESISTANCE OCCURRED WHEN IVUS WAS USED. WHEN VISUALLY CONFIRMED, THE POLYMER JACKET OF THE PRODUCT PEELED OFF WITHIN A RANGE OF APPROXIMATELY 50 CM TO 100 CM FROM THE TIP. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806132 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 201026R031 04562102690023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other