BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18109098 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00018
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 15, 2022
    Report Date
    November 10, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102681007
    PMA / PMN Number
    K203533NA
    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 (VGW1423FL0, VGW1430FL0) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF PEELING OF POLYMER JACKET WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE PRODUCT WAS RETURNED WITH THE MICROCATHETER WHICH WAS USED WITH THE PRODUCT, HAVING BEEN REMOVED FROM THE MICROCATHETER. THE POLYMER JACKET OF THE PRODUCT WAS ROLLED UP AND BELLOWS SHAPE ON THE TIP SIDE, EXPOSING THE CORE WIRE IN THE RANGE OF APPROXIMATELY 60 MM TO 95 MM FROM THE TIP. IN ADDITION, MULTIPLE DAMAGES TO THE POLYMER JACKET WERE OBSERVED IN THE RANGE OF APPROXIMATELY 113 MM TO 127 MM FROM THE TIP. THE MICROCATHETER RETURNED WITH THE PRODUCT WAS CONFIRMED TO HAVE LITTLE OR NO EXTERNAL DAMAGE AND TO BE ABLE TO PASS WATER WITHOUT PROBLEMS. BASED ON THE CONDITION OF THE PRODUCT AND INFORMATION OBTAINED, IT WAS PRESUMED THAT THE DAMAGE AND PEELING OF THE POLYMER JACKET OCCURRED BECAUSE THE MICROCATHETER WAS ADVANCED ALONG THE PRODUCT, AND A VERY HARD OBJECT SUCH AS THE EDGE OF THE TIP OF THE MICROCATHETER CAME INTO STRONG CONTACT WITH THE SURFACE OF THE PRODUCT, CAUSING DAMAGES SUCH AS PRESSURE MARKS ON THE POLYMER JACKET DUE TO EXCESSIVE LOAD. FURTHERMORE, IT WAS PRESUMED THAT THE POLYMER JACKET GOT STUCK IN THE MICROCATHETER DUE TO A PARTIAL TEAR OF THE COATING, AND AS A RESULT, THE PRODUCT COULD NOT BE REMOVED FROM THE MICROCATHETER. 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 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 FLOPPY (THE PRODUCT) WAS USED IN A CASE OF A LESION IN THE BELOW-KNEE AREA WITH SEVERE CALCIFICATION AND OCCLUSION RATE OF 100%. WHEN USED WITH A MICROCATHETER (CORSAIR ARMET, MANUFACTURED BY ASAHI INTECC), THE POLYMER JACKET OF THE PRODUCT PEELED OFF, AND THE POLYMER JACKET GOT STUCK IN THE MICROCATHETER, MAKING DIFFICULT TO REMOVE THE PRODUCT, SO THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY STUCK IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT THE SAME AS THE PRODUCT AND OTHER COMBINATION DEVICE. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93317 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 210203R031 04562102681007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other