BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18117420 · Received November 12, 2023

    Report

    Report Number
    3012223769-2023-00022
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    October 15, 2022
    Report Date
    November 13, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690030
    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] SINCE THE PRODUCT WAS ALREADY DISCARDED IN THE USER FACILITY, THE PRODUCT WAS NOT AVAILABLE FOR THE INVESTIGATION. BASED ON THE INFORMATION OBTAINED, IT WAS PRESUMED THAT THE POLYMER JACKET OF THE PRODUCT MAY HAVE BEEN DAMAGED AND PEELED DUE TO STRONG CONTACT OF THE TIP OF THE PRODUCT WITH THE HARDENED LESION WHILE THE PRODUCT WAS BEING USED INSIDE THE PATIENT'S BODY TO PASS THROUGH A MODERATELY CALCIFIED LESION. 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 OF POLYMER JACKET 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. ~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 MODERATE CALCIFICATION AND OCCLUSION RATE WAS 70% TO LESS THAN 100%. WHEN THE PRODUCT WAS BEING MANIPULATED INSIDE THE PATIENT'S BODY TO PASS THROUGH THE LESION, RESISTANCE TO THE COMBINED DEVICE (PROMINENT, MANUFACTURED BY TOKAI MEDICAL PRODUCTS) OCCURRED, SO THE PRODUCT WAS REMOVED FROM THE BODY AND CHECKED, AND THE POLYMER JACKET WAS PEELED IN AN LOCATION LESS THAN 5 CM FROM THE TIP OF THE PRODUCT. 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
    243438 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 220527R041 04562102690030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other