BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18117521 · Received November 12, 2023

    Report

    Report Number
    3012223769-2023-00031
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    March 17, 2023
    Report Date
    July 19, 2024
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102681069
    PMA / PMN Number
    K213949NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** THE UDI # WAS NOT ENTERED DUE TO OMISSION IN THE INITIAL REPORT SUBMITTED ON 12 NOVEMBER 2023 (EST). WE HAVE RECEIVED A REQUEST FOR RESUBMISSION BY EMAIL FROM FDA'S MDR DATA SYSTEM TEAM, AND WE HEREIN SUBMIT A SUPPLEMENTAL REPORT WITH THE UDI # ADDED.

    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 (VGT1823FL0, VGT1830FL0) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF PEELING OF POLYMER COAT WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE POLYMER JACKET WAS ROLLED UP AT APPROXIMATELY 34 MM FROM THE TIP OF THE PRODUCT AND PULLED TO THE TIP SIDE, EXPOSING THE CORE WIRE IN THE RANGE OF APPROXIMATELY 34 MM TO 40.5 MM FROM THE TIP. WHEN THE ENTIRE CIRCUMFERENCE OF THE ROLLED-UP POLYMER JACKET WAS OBSERVED UNDER MAGNIFICATION, CONSIDERING THE FACT THAT THE POLYMER JACKET THE ENTIRE CIRCUMFERENCE WAS VISIBLE AND THE LENGTH OF THE ROLLED UP CORE WIRE AND THE LENGTH OF THE EXPOSED CORE WIRE, IT WAS DETERMINED THAT THE POLYMER JACKET WAS NOT MISSING. IN ADDITION, PTFE COATING WAS PEELED OFF CIRCUMFERENTIALLY IN THE RANGE OF ABOUT 44 MM TO 59 MM FROM THE TIP, AND THE PTFE COATING WAS PEELED OFF AT ABOUT 81 MM FROM THE TIP. ALTHOUGH DETAILS OF THE PROCEDURE IN THIS CASE COULD NOT BE OBTAINED, BASED ON THE INFORMATION OBTAINED AND CONDITION OF THE PRODUCT, IT WAS PRESUMED THAT THE SURFACE OF THE PRODUCT CAME INTO STRONG CONTACT WITH THE EDGE OF THE DEVICE, SUCH AS A METAL INSERTER, CAUSING PEELING OF THE PTFE COATING AND POLYMER JACKET. IT WAS ALSO PRESUMED THAT THE PEELING OFF OF THE POLYMER JACKET HAS INCREASED RESISTANCE TO THE COMBINED DEVICE AND CAUSED THE POLYMER JACKET TO ROLL UP. 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 THE DETACHED PIECES OF 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 .018 FLOPPY (THE PRODUCT) WAS USED IN A CASE AND COATING WAS PEELED OFF. WE HAVE OBTAINED INFORMATION THAT A COMBINATION DEVICE WAS USED, BUT THE DETAILS ARE UNKNOWN. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238712 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 220330R011 04562102681069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other