BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVC INSIGHT CATHETER HYDROPHILIC

    MDR report key: 6614554 · Received June 6, 2017

    Report

    Report Number
    3004722468-2017-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    January 11, 2017
    Report Date
    April 20, 2017
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K130719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ANGIOGRAMS WERE FORWARDED TO AND EXAMINED BY INFRAREDX. NO UNUSUAL FINDINGS. DEVICE HISTORY RECORD (DHR) FOR CATHETER WAS REVIEWED. NO UNUSUAL FINDINGS. ROOT CAUSE OF COMPLAINT (B)(4) DETERMINED TO BE USER ERROR. POTENTIAL COMPLICATIONS OF DELIVERING AND REMOVING A CATHETER DURING A PROCEDURE WERE REVIEWED WITH USER. NO COMPLAINTS FROM PATIENT AND NO COMPLICATIONS OBSERVED. NO TREATMENT ADMINISTERED AS A RESULT OF PROBLEM USING CATHETER. NO SUBSEQUENT HOSPITALIZATION OF PATIENT REQUIRED. NO FURTHER INVESTIGATION REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    USER FACILITY BELIEVES THAT USE OF EXCESSIVE FORCE LIKELY LED TO CATHETER MALFUNCTION. INCIDENT WAS NOT REPORTED BY THE PHYSICIAN OR USER FACILITY. INCIDENT DISCOVERED BY CHANCE BY COMPANY EMPLOYEE DURING TRAINING.

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION OF LCX AND LAD. CATHETER WAS DELIVERED TO LCX, BUT NO IMAGING PERFORMED. RESISTANCE WAS FELT WHEN PULLING CATHETER FROM LCX. CATHETER MAY HAVE BEEN KINKED. SECOND WIRE MAY HAVE BEEN PRESENT IN LAD. CATHETER AND GUIDEWIRE PULLED TOGETHER INTO THE GUIDE CATHETER. ADDITIONAL RESISTANCE FELT WHEN CATHETER AND GUIDEWIRE REACHED GUIDE CATHETER. MORE FORCE APPLIED TO RETRIEVE CATHETER AND GUIDEWIRE. DISTAL OPAQUE MARKER SECTION OF DISTAL TIP SEPARATED FROM CATHETER. ALL OF CATHETER, GUIDEWIRE, AND GUIDE CATHETER RECOVERED FROM PATIENT. NO INJURY TO PATIENT. NO TREATMENT OF PATIENT DUE TO IMAGING CATHETER MALFUNCTION. ANGIOGRAM UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397217 TVC INSIGHT CATHETER HYDROPHILIC ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OBJ INFRAREDX, INC. TVC-C195-22 F83007

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR