BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18117428 · Received November 12, 2023

    Report

    Report Number
    3012223769-2023-00023
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    October 25, 2022
    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: 3003780911. [MANUFACTURING RECORDS] ALL PRODUCTS WERE CONFIRMED TO HAVE PASSED INSPECTION. [LOT HISTORY REVIEW] WE HAVE RECEIVED ONE CASE OF A SIMILAR EVENT IN THE SAME LOT, BUT AS A RESULT OF THE INVESTIGATION, IT WAS DETERMINED THAT THE EVENT WAS ATTRIBUTABLE TO THE PROCEDURE. [COMPLAINT HISTORY REVIEW] COMPLAINTS ABOUT PRODUCTS OF THE SAME STRUCTURE (VGW1423NS1, VGW1430NS1, VGW1423NS3, VGW1430NS3) 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 POLYMER JACKET OF THE PRODUCT WAS DAMAGED. THE POLYMER JACKET AT APPROXIMATELY 18 MM FROM THE TIP WAS TORN OFF, EXPOSING THE COIL AND CORE WIRE, AND THE COIL WIRE WAS TORN. A DEFORMATION THAT LOOKED AS IF THE COIL HAD BEEN PRESSED WAS ALSO OBSERVED IN THE IMMEDIATE VICINITY. AT A LOCATION APPROXIMATELY 28 MM FROM THE TIP, THE COIL WAS PULLED TOWARD THE TIP, CAUSING THE COIL MISALIGNMENT, AND THE POLYMER JACKET AROUND IT WAS DAMAGED (SCRATCHES CAUSED BY CONTACT WITH A HARD, SHARP OBJECT). AS A RESULT OF OBSERVING THE FRACTURED PART OF THE COIL WITH A SCANNING ELECTRON MICROSCOPE, IT WAS CONFIRMED THAT THERE WERE TRACES OF FRACTURE CAUSED BY APPLYING TWISTING FORCE ON THE CROSS SECTION AND SIDE SURFACE OF THE FRACTURED PART. INTERMITTENT PEELING OF THE PTFE COATING WAS OBSERVED IN THE RANGE FROM APPROXIMATELY 650 MM TO APPROXIMATELY 1500 MM FROM THE TIP. BASED ON THE INFORMATION OBTAINED AND CONDITION OF THE PRODUCT, IT WAS PRESUMED THAT DURING THE PROCEDURE, THE TIP OF THE PRODUCT WAS TRAPPED AND TWISTED IN THE SAME DIRECTION AT THE LESIONED AREA, CAUSING THE COIL TO UNRAVEL AND TEAR OFF, RESULTING IN DAMAGE TO THE POLYMER JACKET AT THE TORN AREA. IT WAS PRESUMED THAT THE PEELING OF THE PTFE COATING WAS CAUSED BY EXCESSIVE CONTACT WITH THE TORQUER WHEN THE TORQUER WAS ATTACHED TO THE PRODUCT AND OPERATED. 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 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

    IT WAS REPORTED THAT VASSALLO GT .014 NS1 (THE PRODUCT) WAS USED IN A CASE OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. AFTER HAVING DIFFICULTY PASSING THROUGH THE LESION, THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS OBSERVED THAT THE TIP WAS DEFORMED. 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
    192924 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 220531R021 04562102690047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other