BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18117418 · Received November 12, 2023

    Report

    Report Number
    3012223769-2023-00021
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    July 14, 2022
    Report Date
    November 13, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690047
    PMA / PMN Number
    K203529
    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)(4)) 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 CORE WIRE WAS EXPOSED IN A RANGE OF APPROXIMATELY 525 MM TO 575 MM FROM THE TIP OF THE PRODUCT, AND THE POLYMER JACKET WAS PEELED OFF AND ROLLED UP AND GATHERED INTO BELLOWS SHAPE AT THE CENTER OF THE EXPOSED CORE WIRE (IN A RANGE OF APPROXIMATELY 538 MM TO 546 MM FROM THE TIP). A PORTION OF THE DETACHED POLYMER JACKET WAS GATHERED INTO BELLOWS SHAPE TO THE PROXIMAL END AND MOVED TO APPROXIMATELY 635 MM FROM THE TIP. IN ADDITION, STREAKY PEELING OF THE PTFE COATING WAS OBSERVED AT APPROXIMATELY 605 MM FROM THE TIP. BASED ON THE CONDITION OF THE PRODUCT AND INFORMATION OBTAINED, IT WAS PRESUMED THAT WHEN THE PRODUCT WAS BEING OPERATED WITH A TORQUER ATTACHED, EXCESSIVE CONTACT WITH THE TORQUER CAUSED DAMAGE TO THE POLYMER JACKET OF THE PRODUCT, AND THE DAMAGE CAUSED RESISTANCE TO THE COMBINED DEVICE (THROMBUS ASPIRATION CATHETER) BY BEING CAUGHT ON THE GUIDE WIRE LUMEN OF THE COMBINED DEVICE, RESULTING IN THE BELLOWS SHAPE PEELING OF THE POLYMER JACKET. IT WAS ALSO PRESUMED THAT THE STREAKY PEELING OF THE PTFE COATING MAY HAVE BEEN CAUSED BY EXCESSIVE CONTACT WITH THE TORQUER. 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] ~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 NS1 (THE PRODUCT) WAS USED IN A CASE OF AN IN-STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. AFTER ASPIRATING THROMBUS WITH A THROMBUS ASPIRATION CATHETER SEVERAL TIMES, THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY BECAUSE THRERE WAS A RESISTANCE BETWEEN THE PRODUCT AND THE THROMBUS ASPIRATION CATHETER. AND THEN, PEELING OF THE POLYMER JACKET OF THE PRODUCT WAS OBSERVED. THE PROCEDURE WAS COMPLETED 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
    243436 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 220528R021 04562102690047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other