BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST KODAMA CATHETER

    MDR report key: 5321304 · Received December 22, 2015

    Report

    Report Number
    2134243-2015-00014
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 2, 2015
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K113008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE KODAMA CATHETER WAS RECEIVED AT ACIST MEDICAL SYSTEMS, INC. ON DECEMBER 2, 2015. EVALUATION OF THE RETURNED CATHETER CONFIRMED THAT THE TIP OF CATHETER WAS MISSING (APPROXIMATELY 0.75 CM). REMAINING TIP SHOWED SIGNS OF ELONGATION. IT APPEARS THAT SOME FORCE WAS APPLIED WHILE THE TIP WAS RESTRAINED, AND THE TIP STRETCHED AND THEN BROKE OFF. BASED ON REVIEW OF THE REPORTED COMPLAINT AND ANALYSIS OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    AFTER COMPLETION OF AN INTRAVASCULAR ULTRASOUND (IVUS) STUDY USING THE ACIST HDI HIGH-DEFINITION IVUS SYSTEM AND ACIST KODAMA CATHETER, WHEN THE KODAMA CATHETER WAS REMOVED FROM THE GUIDE CATHETER, THE USER OBSERVED THAT THE CATHETER TIP WAS MISSING. THE PHYSICIAN PERFORMED AN X-RAY OF THE PATIENT TO LOCATE THE CATHETER TIP; THE CATHETER TIP WAS NOT LOCATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845517 ACIST KODAMA CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ ACIST MEDICAL SYSTEMS, INC. 00063048

    Patients

    Seq Age Sex Outcome Treatment
    1