BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45 MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 3960087 · Received May 29, 2014

    Report

    Report Number
    2939520-2014-00043
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW: THIS STERILE COVER IS PROVIDED WITH THE REVOLUTION CATHETER. THE COVER ITSELF IS A PURCHASED ITEM. A REVIEW OF THE INSPECTION RECORDS FOR THE STERILE DRAPE INDICATES THAT THERE WERE NO IDENTIFIED QUALITY CONFORMANCE ISSUES ASSOCIATED WITH THE COMPONENT LOT. THE STERILE DRAPE WAS EVALUATED UNDER MAGNIFICATION AND THE RESULTS DETERMINED THAT THE DEFECT NOTED DURING USE WAS NOT A HOLE, BUT RATHER A SCRAPE ON THE MATERIAL AND THERE WAS NO DETECTABLE BREACH IN THE INTEGRITY OF THE COVER. IN ADDITION, THE STERILE DRAPE IS PACKAGED WITHIN A TYVEK/POLY POUCH AND STERILIZED WITH THE DEVICE. THERE WERE NO INDICATIONS OF A BREECH IN THE OUTER STERILE BARRIER CONTAINING THE DRAPE. THESE RESULTS WERE REVIEWED WITH THE STAFF MICROBIOLOGIST AND THE DETERMINATION WAS MADE THAT THERE WERE NO INDICATIONS THAT ANY STERILITY BREECH OCCURRED THAT WOULD IMPACT THE STERILITY OF THE DRAPE EITHER BEFORE OR DURING USE. THE OBSERVED DEFECT IS PRIMARILY COSMETIC IN NATURE, NOT AFFECTING THE FUNCTION OF THE DRAPE. THIS REPORT IS BEING SUBMITTED BASED ON THE NATURE OF THE ORIGINAL INFO REPORTING A STERILITY BREECH. THE IDENTIFIED FAILURE WAS NOT CONFIRMED. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES. NO FURTHER ACTION IS REQUIRED AT THIS TIME AND NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING THE OPERATION CHECK, PRIOR TO ARTERIAL INSERTION, THE USER OBSERVED A HOLE ON THE STERILE EQUIPMENT COVER NEAR THE NO. 3 PORTION. SINCE THE SURGICAL PREPARATION INITIATED PRIOR TO NOTICING THE HOLE, ONCE THE HOLE WAS DISCOVERED, ALL THE STERILIZED SURGICAL EQUIPMENT WAS DEEMED AS NON-STERILE AND WERE NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315595 REVOLUTION 45 MHZ ROTATIONAL IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 0035 50007218

    Patients

    Seq Age Sex Outcome Treatment
    1