BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18117635 · Received November 13, 2023

    Report

    Report Number
    3012223769-2023-00033
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    March 20, 2023
    Report Date
    November 13, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690047
    PMA / PMN Number
    K203529NA
    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 (B)(6) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF POLYMER JACKET PEELING WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THE POLYMER JACKET PEELED OFF AT A LOCATION APPROXIMATELY 78 MM FROM THE TIP OF THE PRODUCT AND ALSO DAMAGED FROM THE PROXIMAL END TOWARD THE TIP. THE POLYMER JACKET HAD SPIRAL DENTS AT ABOUT 112 MM FROM THE TIP, AND THE POLYMER JACKET WAS DAMAGED AND PEELED OFF FROM THE PROXIMAL END TO THE TIP SIDE AT ABOUT 440 MM FROM THE TIP AND IN THE RANGE FROM 470 MM TO 477 MM FROM THE TIP. STREAKY PEELING OF THE PTFE COATING WAS OBSERVED IN THE RANGE OF APPROXIMATELY 760 MM TO 840 MM FROM THE TIP, AND PEELING OF THE PTFE COATING (ABRASION MARKS BY A TORQUER) WERE OBSERVED IN THE RANGE OF APPROXIMATELY 1190 MM TO 1290 MM FROM THE TIP AND AT THE POSITION OF APPROXIMATELY 1968 MM FROM THE TIP. IN ADDITION, THERE WAS A DAMAGE OF POLYMER JACKET AT ABOUT 520 MM FROM THE TIP, AND THE ENTIRE CORE WIRE WAS BROKEN AT THE CONNECTING PIPE, AND THE BROKEN CORE WIRE WAS BENT. DIMPLES WERE ALSO OBSERVED ON THE FRACTURE SURFACE OF EACH CORE WIRE AND CONNECTING PIPE. BASED ON THE CONDITION OF THE PRODUCT AND INFORMATION OBTAINED, IT WAS PRESUMED THAT THE SEPARATION AND DENTS OF THE POLYMER JACKET FROM THE TIP TO APPROXIMATELY 112 MM WERE CAUSED BY CONTACT OF THE METAL TIP OF THE COMBINED DEVICE WITH THE POLYMER JACKET OF THE PRODUCT WHEN THE COMBINED DEVICE WAS PUSHED OR PULLED ALONG THE PRODUCT NEAR A SEVERELY CALCIFIED LESION. THE DAMAGE AND PEELING OF THE POLYMER JACKET APPROXIMATELY 440 MM TO 840 MM FROM THE TIP AND THE PEELING OF THE PTFE COATING MAY HAVE OCCURRED WHEN THE COMBINED DEVICE WAS PRESSED WHILE THE PRODUCT WAS CURVED. THE SEPARATION WAS PRESUMED TO HAVE BEEN CAUSED BY UNINTENTIONAL EXCESSIVE LOADING DURING USE OR REMOVAL FROM THE PATIENT'S BODY, RESULTING IN BENDING AND DAMAGING, AND THEN BEING SEPARATED WHEN THE DEVICE WAS STRETCHED AFTER REMOVING FROM THE BODY. 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 DETACHED PIECES 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 .014 NS1 (THE PRODUCT) WAS USED IN A CASE OF A LESION IN BELOW-KNEE AREA WITH SEVERE CALCIFICATION AND OCCLUSION RATE WAS (B)(4) TO LESS THAN (B)(4). A SHEATH (PARENT SELECT, MANUFACTURED BY MEDIKIT) AND PENETRATING CATHETER (CORSAIR ARMET, MANUFACTURED BY ASAHI INTECC) WERE USED TOGETHER TO ADVANCE THE PRODUCT, AND THE PRODUCT WAS USED IN THE POPLITEAL ARTERY AND ANTERIOR TIBIAL ARTERY. WHEN THE PRODUCT WAS REMOVED IN ORDER TO CHANGE THE TIP SHAPE TO TRY THE PERONEAL ARTERY, IT WAS TORN OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT (DETAILS UNKNOWN) AND THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235805 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 220901R031 04562102690047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other