BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 18108687 · Received November 10, 2023

    Report

    Report Number
    3012223769-2023-00010
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    August 13, 2021
    Report Date
    November 10, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102690016
    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]NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. [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] A KINK WITH A BREAKAGE OF THE CONNECTING PIPE OCCURRED AT APPROXIMATELY 516 MM FROM THE TIP OF THE PRODUCT (AT THE POINT WHERE THE CORE WIRE ON THE TIP SIDE WAS CONNECTED TO THE CORE WIRE ON THE PROXIMAL SIDE), AND THE CONNECTING PIPE WAS BROKEN AT APPROXIMATELY 523 MM FROM THE TIP OF THE PRODUCT. THE POLYMER JACKET NEAR THE FRACTURED AREA WAS DAMAGED, AND A STREAKY ABRASION WAS OBSERVED APPROXIMATELY 510 MM TO 513 MM FROM THE TIP. AFTER REMOVAL OF THE POLYMER JACKET, THE FRACTURED AREA WAS OBSERVED UNDER A SCANNING ELECTRON MICROSCOPE. DIMPLES CAUSED BY THE STRETCHING LOAD WERE OBSERVED IN THE CROSS SECTION OF THE CONNECTING PIPE, TEARS WERE OBSERVED IN THE CORE WIRE IN THE CONNECTING PIPE DUE TO THE BENDING LOAD APPLIED, AND DIMPLES CAUSED BY THE STRETCHING LOAD APPLIED WERE OBSERVED ON THE FRACTURED SURFACE. INTERMITTENT DELAMINATION OF THE PTFE COATING OCCURRED AT THE PROXIMAL END. BASED ON THE INFORMATION OBTAINED AND CONDITION OF THE PRODUCT, IT WAS PRESUMED THAT AFTER PASSING THROUGH THE LESION WITH THE PRODUCT, WHEN THE CONNECTING PIPE OF THE PRODUCT WAS PUSHED AND PULLED IN THE VASCULAR ANASTOMOSIS OR THE BALLOON CATHETER WAS ADVANCED ALONG THE PRODUCT, A STRONG BENDING LOAD WAS REPEATEDLY APPLIED AT THE SAME POINT, WHICH MAY HAVE RESULTED IN KINKING AND TEARING OF THE CONNECTING PIPE WITH SEPARATION. SINCE THE DAMAGES TO THE POLYMER JACKET WERE CONCENTRATED NEAR THE FRACTURED AREA, IT WAS PRESUMED THAT STRONG SLIDING RESISTANCE WAS GENERATED BETWEEN THE PRODUCT WHICH WAS CURVED AND THE COMBINED BALLOON CATHETER DURING THE PROCESS OF ADVANCING THE BALLOON CATHETER ALONG THE PRODUCT, WHICH MAY HAVE CAUSED THE DAMAGE. AS A RESULT OF ABOVE INVESTIGATION, ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO PRODUCT QUALITY BUT TO THE PROCEDURE, ADDITIONAL INTERVENTION WAS PERFORMED TO REMOVE THE SEPARATED PART OF THE PRODUCT AND ALSO 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 NS3 (THE PRODUCT) WAS USED IN A CASE OF A LESION IN ANASTOMOSIS SITE OF SHUNT WITH SEVERE TORTUOSITY AND OCCLUSION RATE WAS 70% TO LESS THAN 100%. AFTER PUNCTURING THE ARTERY AND PASSING THROUGH THE STENOSIS SITE, A BALLOON CATHETER (SCORE FLEX, MANUFACTURED BY ORBUSNEICH MEDICAL) WAS DELIVERED, BUT IT DID NOT PASS EASILY AND THE PRODUCT SEEMED TO BE BENT SEVERAL TIMES AT THE ANASTOMOSIS. THE BALLOON CATHETER WAS DELIVERED AS IT WAS AND DILATATION WAS PERFORMED. AFTER DILATION, THE PRODUCT WAS FOUND TO HAVE BEEN BROKEN OFF IN THE PATIENT'S BODY. THE BALLOON CATHETER AND THE BROKEN PART OF THE PROXIMAL SIDE OF THE PRODUCT WERE REMOVED FROM THE PATIENT'S BODY, FOLLOWED BY PUNCTURE FROM THE VENOUS SIDE, AND THE REMAINING PORTION OF THE PRODUCT WAS REMOVED FROM THE PATIENT'S BODY USING A SNARE CATHETER FROM THE VENOUS SIDE. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806102 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 210215R031 04562102690016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O