BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18109035 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00016
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    May 19, 2022
    Report Date
    November 10, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102681045
    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 (VGW1419G14, VGW1419G40) 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] SINCE THE PRODUCT WAS ALREADY DISCARDED IN THE USER FACILITY, THE PRODUCT WAS NOT AVAILABLE FOR THE INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THIS PRODUCT WAS USED IN CTO CASE WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION, AND IT WAS PRESUMED THAT IN THE PROCESS OF ATTEMPTING TO PASS THROUGH THE LESION, THE TIP OF THE PRODUCT WAS TRAPPED IN THE CALCIFIED AREA, AND IN THAT STATE, A ROTATIONAL LOAD WAS CONTINUOUSLY APPLIED IN THE SAME DIRECTION AND IT CAUSED A SEPARATION. AS A RESULT OF ABOVE, IT WAS DETERMINED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO THE QUALITY OF THE PRODUCT, BUT WE HAVE RECEIVED INFORMATION FROM THE DISTRIBUTOR THAT "AS ONLY THE TORN PIECE REMAINED WITHIN THE CTO AREA, THE PROCEDURE WAS COMPLETED WITHOUT ANY ATTEMPT TO RETRIEVE IT". THEREFORE, IT WAS DETERMINED THAT THE TORN PIECE 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 G40 (THE PRODUCT) WAS USED IN A CASE OF A CTO WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. DURING THE PROCEDURE, THE PRODUCT WAS TRAPPED IN THE CTO LESION, AND WHEN THE PRODUCT WAS ROTATED, ABOUT 2 CM FROM THE TIP WAS SEPARATED. AN ATTEMPT WAS MADE TO PASS THE CTO AREA BY REPLACING THE PRODUCT WITH NON-FILMECC GUIDE WIRE, BUT IT DID NOT PASS, AND THE PROCEDURE WAS COMPLETED WITHOUT PENETRATING THE CTO LESION. A PORTION APPROXIMATELY 2 CM FROM THE TIP OF THE PRODUCT WAS SEPARATED AND REMAINED IN THE PATIENT'S BODY, BUT WE RECEIVED THE INFORMATION THAT "AS ONLY THE TORN PIECE REMAINED WITHIN THE CTO AREA, THE PROCEDURE WAS COMPLETED WITHOUT ANY ATTEMPT TO RETRIEVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945175 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 211001R041 04562102681045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability