BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18109121 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00019
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    June 28, 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: (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 (VGW1419G14, VGW1419G40) OVER THE PAST THREE YEARS SHOWED THAT THE NUMBER OF EVENTS OF PEELING OF PTFE COATING WAS SMALL AND DID NOT SHOW AN INCREASING TREND. [RETURNED PRODUCT INVESTIGATION] THERE WERE KINKS AT APPROXIMATELY 142 MM, 167 MM, AND 174 MM FROM THE TIP OF THE PRODUCT. THERE WAS STREAKY PEELING OF THE PTFE COATING IN THE RANGE OF APPROXIMATELY 600 MM TO 635 MM FROM THE TIP OF THE PRODUCT, AND PEELING THAT APPEARS TO BE GRIPPING MARKS OF THE TORQUER WERE FOUND ON THE CIRCUMFERENCE AT POSITIONS APPROXIMATELY 792 MM, 825 MM, AND 835 MM FROM THE TIP. THEY WERE EQUALLY SPACED ABOUT 90 DEGREES APART. FURTHERMORE, THERE WERE PEELING OF THE PTFE COATING AROUND THE ENTIRE CIRCUMFERENCE AT MULTIPLE LOCATIONS WITHIN A RANGE OF APPROXIMATELY 745 MM TO 840 MM FROM THE TIP. BASED ON THE CONDITION OF THE PRODUT AND INFORMATION OBTAINED, IT WAS PRESUMED THAT THE STREAKY PEELING OF THE PTFE COATING WAS CAUSED BY EXCESSIVE CONTACT WITH THE TORQUER CAUSED BY MOVING THE TORQUER ATTACHED TO THE PRODUCT WITHOUT SUFFICIENTLY LOOSENING IT AND THE PEELING AROUND THE ENTIRE CIRCUMFERENCE WAS DUE TO POOR FIXATION BETWEEN THE TORQUER AND THE PRODUCT, WHICH CAUSED THE TORQUER TO SPIN IDLY DURING OPERATION, LEADING TO THE PEELING AROUND THE ENTIRE CIRCUMFERENCE. REGARDING THE KINK, IT WAS ASSUMED THAT PEELED PIECES OF THE PTFE COATING WERE ENTERED THE GUIDE WIRE LUMEN OF THE COMBINED DEVICE, CREATING RESISTANCE AND CAUSING THE KINK. 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 THE PEELED PIECES OF PTFE COATING 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. [HOW TO USE]: 3. PROCEDURES FOR INSERTION OVER THE WIRE SYSTEM: G) INSERT THE TORQUE DEVICE FROM THE PROXIMAL END OF THE GUIDEWIRE IF NECESSARY, AND MANIPULATE THE GUIDEWIRE VIA THE TORQUE DEVICE. WHEN REPOSITIONING THE TORQUE DEVICE OVER THE GUIDEWIRE, ENSURE THAT THE TORQUE DEVICE IS RELEASED COMPLETELY FROM THE GUIDEWIRE PRIOR TO REPOSITIONING. DO NOT ATTACH THE TORQUE DEVICE OVER THE HYDROPHILIC COATING. RAPID EXCHANGE SYSTEM: E) INSERT THE TORQUE DEVICE FROM THE PROXIMAL END OF THE GUIDEWIRE IF NECESSARY, AND MANIPULATE THE GUIDEWIRE VIA THE TORQUE DEVICE. WHEN REPOSITIONING THE TORQUE DEVICE OVER THE GUIDEWIRE, ENSURE THAT THE TORQUE DEVICE IS RELEASED COMPLETELY FROM THE GUIDEWIRE PRIOR TO REPOSITIONING. DO NOT ATTACH THE TORQUE DEVICE OVER THE HYDROPHILIC COATING. [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 LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH SEVERE CALCIFICATION AND OCCLUSION RATE WAS 100%. WHEN USED IN COMBINATION WITH IVUS CATHETER, ABOUT 200MM FROM THE TIP OF THE PRODUCT WAS BROKEN AT THE EXIT PORT OF IVUS, MAKING IT NO LONGER USABLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER PRODUCT OF THE SAME TYPE OF THE PRODUCT, AND THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806166 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 211103R031 04562102681045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other