BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 7249709 · Received February 7, 2018

    Report

    Report Number
    3004722468-2017-00005
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 7, 2018
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOR #13 AND #15 TANDEM LESIONS, ULTIMASTER 3.5X12, 2.5X12 WAS IMPLANTED THEN OCT WAS PERFORMED. SINCE THE DISTAL EDGE OF THE STENT FOR #13 WAS NOT JOINING WELL TO THE VESSEL WALL, OCT CATHETER WAS CAUGHT DURING REMOVAL, BUT THE CATHETER WAS SUCCESSFULLY REMOVED. THEN, TVC CATHETER WAS INSERTED; HOWEVER IT WAS UNABLE TO REACH #15. THEREFORE ATTEMPTED A PULLBACK FROM #13 STENTING AREA TO THE PROXIMAL, HOWEVER IT WAS STUCK AT THE STENT DISTAL EDGE AND PULLBACK FAILED. THE OPERATOR TRIED THE CATHETER TO PUSH TO DISTAL WITH APPLYING TORQUE HOWEVER IT DID NOT ADVANCE. THEREFORE CUT OFF THE CATHETER SHAFT AND REMOVED THE IMAGING CORE AND RAGIFORCUS GUIDE WIRE0.018 WAS INSERTED INSIDE THE CATHETER. HOWEVER IT DID NOT ADVANCE FURTHER CORONARY OSTIUM AND APPLIED TORQUE IN THIS CONDITION BUT THE SITUATION DID NOT CHANGE. NEXT, THE PROXIMAL END OF THE SAME RADIFORCUS WAS INSERTED; IT PASSED DIFFERENTLY FROM THE CATHETER SHAFT AT THE CORONARY OSTIUM. IT WAS CONSIDERED IF GW BROKE THROUGH THE CATHETER SHAFT AND THEN REMOVED. ALSO THE OPERATOR ATTEMPTED GUIDELINER 5.5 BUT IT ALSO FAILED INSERTION. LASTLY ATTEMPTED TO PUSH THE CATHETER ONLY TO THE DISTAL AND APPLIED TORQUE AND PULLED, CATHETER WAS REMOVED FINALLY. DEFORMATION WAS CONFIRMED AT THE DISTAL EDGE OF THE STENT BUT ANOTHER INFLATION WAS TAKEN BY HP BALLOON AND THE PROCEDURE WAS COMPLETED. THE CAUSE OF THE STUCK WAS PROBABLY THE STENT EDGE, THE OPERATOR IS REQUESTING TO CONFIRM THE CAUSE AND ABOUT INVESTIGATE 0.018GW INSERTION FAILURE. ALSO PLEASE INVESTIGATE IF 0.018 GW BROKE THROUGH THE CATHETER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93341 TVC INSIGHT CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-20 G48652 00857595006104

    Patients

    Seq Age Sex Outcome Treatment
    1