BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18108540 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00005
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 16, 2021
    Report Date
    November 10, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102681014
    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: 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 (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] 3D DEFORMATION WAS OBSERVED AT APPROXIMATELY 130 MM FROM THE TIP OF THE PRODUCT. THE POLYMER JACKET WAS DAMAGED AT APPROXIMATELY 120 MM AND 130 MM FROM THE TIP, AND ABRASION SCRATCHES WERE OBSERVED ON THE POLYMER JACKET IN THE RANGE OF APPROXIMATELY 150 MM TO 185 MM FROM THE TIP. IN ADDITION, STREAKY PEELING OF THE PTFE COATING WAS OBSERVED IN THE RANGE OF APPROXIMATELY 210 MM TO 260 MM FROM THE TIP, AND ALSO OBSERVED STREAKY PEELING OF THE PTFE COATING INTERMITTENTLY IN A WIDE RANGE OF APPROXIMATELY 530 MM TO 650 MM FROM THE TIP. BASED ON THE INFORMATION OBTAINED AND CONDITION OF THE PRODUCT, IT WAS PRESUMED THAT RESISTANCE WAS CAUSED WHEN THE TIP OF THE PRODUCT WAS PASSED THROUGH THE LESION WITH CALCIFICATION AND STENOSIS, AND THAT THE PRODUCT WAS PUSHED, PULLED, OR ROTATED UNDER SUCH CONDITIONS, RESULTING IN 3D DEFORMATION DUE TO EXCESSIVE BENDING AND TWISTING LOADS THAT EXCEEDED THE PRODUCT'S CAPABILITY. IT WAS ALSO PRESUMED THAT THE EDGES OF METAL INSERTERS, SHAPING NEEDLES, ETC. STRONGLY CONTACTED THE SURFACE OF THE PRODUCT IN ITS CURVED STATE, AND EXCESSIVE LOAD WAS APPLIED, RESULTING IN DAMAGE AND ABRASION OF THE POLYMER JACKET AND STREAKY PEELING OF THE PTFE COATING. 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 OF COATING WERE LEFT BEHIND IN THE PATIENT'S BODY. INSTRUCTIONS FOR USE (IFU) STATES BELOW AND NO CAPA WILL BE TAKEN. [WARNINGS]: NEVER USE METALLIC CANNULA OR METALLIC SHEATH TUBE AND WITHDRAWAL OF THE GUIDE WIRE. [OTHERWISE, 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 SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION AND OCCLUSION RATE OF 70% TO LESS THAN 100%. THE ANTERIOR TIBIAL ARTERY (ATA) APPROACH WAS PERFORMED SEVERAL TIMES TO FIND THE LESION, BUT THE TIP OF THE PRODUCT DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT OF THE SAME TYPE OF THE PRODUCT AND THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92347 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 201221R071 04562102681014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other