BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18108960 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00014
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    February 3, 2022
    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: (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 SEPARATION WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE TIP OF THE PRODUCT WAS MISSING DUE TO THE SEPARATION. AS A RESULT OF MEASURING THE COIL LENGTH, IT WAS FOUND TO BE APPROXIMATELY 90 MM, INDICATING THAT APPROXIMATELY 30 MM FROM THE TIP WAS MISSING DUE TO THE SEPARATION. BASED ON THE CONDITION OF THE PRODUCT AND INFORMATION OBTAINED, DURING THE PROCEDURE, THE TIP OF THE PRODUCT GOT STUCK IN THE SEVERELY CALCIFIED LESION, AND CONTINUOUS ROTATIONAL LOAD WAS APPLIED WHILE THE TIP WAS TRAPPED, CAUSING THE CORE WIRE TO BREAK, AND THEN CONTINUE TO MOVE IN THE SAME DIRECTION. IT WAS PRESUMED THAT THE COIL WAS TWISTED DUE TO THE ROTATIONAL LOAD APPLIED, WHICH RESULTED IN THE COIL SEPARATION. AS A RESULT OF ABOVE INVESTIGATION, IT WAS DETERMINED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO THE PRODUCT QUALITY, BUT WE HAVE RECEIVED INFORMATION FROM THE DISTRIBUTOR THAT "IMPERMEABLE PARTS REMAIN IN THE BODY, CAUSED THE HEALTH DAMAGE TO PATIENTS." THEREFORE, IT WAS DETERMINED THAT THE FRACTURED FRAGMENTS CAUSED BY THE PRODUCT'S SEPARATION REMAINED IN THE PATIENT'S BODY. INSTRUCTIONS FOR USE (IFU) STATES BELOW AND NO CAPA WILL BE TAKEN. [WARNINGS]: ~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. ~WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. ~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 TORTUOSITY AND SEVERE CALCIFICATION, AND OCCLUSION RATE WAS 100%. THE TIP OF THE PRODUCT GOT STUCK IN THE CALCIFIED LESION, AND WHEN IT WAS PULLED A LITTLE, THERE WAS NOT MUCH RESISTANCE AND IT WAS BROKEN. AN ATTEMPT WAS MADE TO RETRIEVE THE TORN PIECE, BUT THE TIP PART REMAINED INSIDE THE PATIENT'S BODY AND THE PROCEDURE ENDED. FROM THE DISTRIBUTOR, IT WAS REPORTED THAT "THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL INTERVENTION FOR THE TORN PIECE, BUT THIS WAS NOT A MAJOR PROBLEM AS THE BLOOD VESSEL WAS ORIGINALLY A CTO. ALSO, BECAUSE THE COLLATERALS HAD DEVELOPED, THE CONDITION DID NOT BECOME FATAL AND REMAINED MOSTLY UNCHANGED FROM BEFORE THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866974 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 210609R051 04562102681014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability