BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 4177324 · Received April 28, 2014

    Report

    Report Number
    2939520-2014-00035
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 3, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR A SIMILAR FAILURE MODE WITHIN THIS LOT. THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER THEREFORE A DEVICE EVAL HAS NOT BEEN PERFORMED. PER VOLCANO'S MDR CORPORATE POSITION, THIS CASE IS BEING REPORTED SINCE A PORTION OF THE CATHETER BROKE OFF WHILE INSIDE THE PT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE REVOLUTION CATHETER WAS USED IN A PROCEDURE TO TREAT A SLIGHTLY TORTUOUS AND CALCIFIED LESION. THE CUSTOMER REPORTED THAT THE REVOLUTION CATHETER BECAME DETACHED DURING PULLBACK INSIDE THE VESSEL WHILE INSPECTING STENT APPOSITION. THE CATHETER WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE PHYSICIAN REPORTED THAT NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE AND THE CATHETER DID NOT GET STUCK INSIDE THE LESION OR TO ANY OTHER DEVICES. THE PHYSICIAN USED A BALLOON CATHETER TO DILATE THE VESSEL IN ORDER TO REMOVE THE DISTAL PORTION OF THE CATHETER. ALL PORTIONS OF THE CATHETER WERE ACCOUNTED FOR UPON REMOVAL AND NO PORTIONS WERE LEFT INSIDE THE PT. AFTER REMOVING THE DAMAGED CATHETER, THE DOCTOR ENDED THE PROCEDURE WITHOUT ANY FURTHER ACTION. THERE WAS NO REPORT OF PT INJURY OR ADVERSE EVENT DUE TO THE DEVICE MALFUNCTION. THE PT WAS RELEASED FROM THE HOSPITAL ACCORDING TO THE ORIGINAL TREATMENT PLAN AND IS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254525 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 0035 20011100

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention