BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18109010 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00015
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    February 4, 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 ((B)(6)) 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 COIL WAS UNRAVELED AT APPROXIMATELY 80 MM FROM THE TIP OF THE PRODUCT AND COIL WAS SEPARATED PARTLY AT THE UNRAVELED LOCATION. ADDITIONALLY, PEELING OF THE PTFE COATING OCCURRED IN MULTIPLE LOCATIONS WITHIN A RANGE OF APPROXIMATELY 740 MM TO 1050 MM FROM THE TIP OF THE PRODUCT. SINCE THE PEELING OCCURRED ON THE ENTIRE CIRCUMFERENCE OR IN STREAKS AT EQUAL INTERVALS OF ABOUT 90 DEGREES ON THE CIRCUMFERENCE, IT WAS PRESUMED THAT THE ROTATIONAL LOAD WAS APPLIED WITHOUT THE TORQUER BEING SUFFICIENTLY FIXED, WHICH LED TO THE PEELING ON THE ENTIRE CIRCUMFERENCE. ALTERNATIVELY, IT WAS PRESUMED THAT THE TORQUER WAS MOVED WITHOUT BEING SUFFICIENTLY LOOSENED, LEADING TO THE STREAKY PEELING. BASED ON THE CONDITION OF THE PRODUT, IT WAS PRESUMED THAT DURING THE PROCEDURE, THE COIL UNRAVELED DUE TO CONTINUOUS ROTATION IN THE SAME DIRECTION WHILE THE TIP OF THE PRODUCT WAS FIXED, AND FURTHERMORE, IT WAS PRESUMED THAT THE UNRAVELED PART OF THE COIL CAME INTO CONTACT WITH THE LESION OR THE CONCOMITANT DEVICE AND LOCAL LOAD WAS APPLIED, WHICH RESULTED IN THE COIL SEPARATION. 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 FRACTURED FRAGMENTS WERE LEFT BEHIND 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

    WE RECEIVED A COMMENT FROM THE PHYSICIAN THAT "WHEN I TOOK VASSALLO GT .014 G40 (THE PRODUCT) OUT OF THE HOLDER TUBE AND TRIED TO USE IT, I FOUND A BEAD-LIKE BUMP ABOUT 80 MM FROM THE TIP, SO I STOPPED USING IT." HOWEVER, BASED ON THE CONDITION OF PEELING OF THE PTFE COATING ON THE PROXIMAL SIDE OF THE RETURNED PRODUCT, IT WAS CONFIRMED THAT THE PRODUCT HAD BEEN USED FOR THE PROCEDURE WITH A TORQUER ATTACHED, SO IT WAS DETERMINED THAT THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING A NON-FILMECC GUIDE WIRE, AND THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833592 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 210802R031 04562102681045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other