BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18108491 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00004
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 4, 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: (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) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF CRACK OF THE CONNECTING PIPE WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THIS PRODUCT HAS A STRUCTURE IN WHICH THE NI-TI CORE WIRE (APPROXIMATELY 500 MM LONG FROM THE TIP) AND THE SUS CORE WIRE ON THE PROXIMAL SIDE ARE CONNECTED USING A CONNECTING PIPE AT 500 MM FROM THE TIP. THE PRODUCT KINKED AT ABOUT 500 MM FROM THE TIP (AT THE BOUNDARY BETWEEN THE CORE WIRE AND THE CONNECTING PIPE ON THE TIP SIDE), CAUSING A CRACK OF ABOUT 0.8 MM IN THE LONGITUDINAL DIRECTION IN THE CONNECTING PIPE AT THAT LOCATION, AND THE POLYMER JACKET PEELED OFF IN A LENGTH OF ABOUT 2 MM. A STREAKY ABRASION SCRATCH WAS OBSERVED ON THE POLYMER JACKET IN THE RANGE OF APPROXIMATELY 570 MM TO 580 MM FROM THE TIP OF THE PRODUCT. IN ADDITION, THE PTFE COATING PEELED OFF INTERMITTENTLY. BASED ON THE CONDITION OF THE PRODUCT AND INFORMATION OBTAINED, IT AS PRESUMED THAT THE CRACKS IN THE CONNECTING PIPE WERE CAUSED BY THE KINKING OF THE TIP SIDE CORE WIRE DUE TO THE LOCAL BENDING LOAD APPLIED AT THE BOUNDARY BETWEEN THE TIP SIDE CORE WIRE AND THE CONNECTING PIPE, AND THE LOAD WAS THEN APPLIED FROM THE INSIDE OF THE CONNECTING PIPE TO THE OUTSIDE. REGARDING THE PEELING OF THE POLYMER JACKET AND THE PEELING OF THE PTFE COATING, AS A RESULTS OF REPRODUCTION TESTS CONDUCTED BY FILMECC SO FAR, IT WAS PRESUMED TO BE CAUSED BY THE SHARP TIP OF SOME KIND OF DEVICE, SUCH AS ONE WITH A METAL TIP, RUBBING AGAINST THE SURFACE OF THE PRODUCT. AS A RESULT OF ABOVE INVESTIGATION, ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO THE PRODUCT QUALITY BUT TO THE PROCEDURE, WE CANNOT COMPLETELY RULE OUT THE POSSIBILITY THAT FRACTURED FRAGMENTS 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 A LESION IN THE SUPERFICIAL FEMORAL ARTERY AND ITS OCCLUSION RATE WAS 70% TO LESS THAN 100%. WHEN ATTEMPTING TO DELIVER A STENT (ELUVIA, MANUFACTURED BY BOSTON SCIENTIFIC JAPAN) USING THIS PRODUCT, THE SHAFT OF THE PRODUCT KINKED. AFTER THAT, IT WAS REPLACED WITH A NEW PRODUCT, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806084 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 180818R011 04562102690023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other