BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ IVUS IMAGING CATHETER

    MDR report key: 6065437 · Received October 28, 2016

    Report

    Report Number
    2939520-2016-00080
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 22, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO OBTAIN PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL. ATTEMPTS TO OBTAIN THE PATIENT INFORMATION WERE MADE VIA EMAIL AND PHONE. ALL REASONABLY KNOWN PATIENT INFORMATION IS INCLUDED IN THIS REPORT. RELEVANT INFO: NO TESTS/LABORATORY DATA WAS AVAILABLE. OTHER RELEVANT HISTORY: NO INFORMATION WAS AVAILABLE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO THE ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 1

    THIS CASE WAS INVESTIGATED IN ACCORDANCE WITH THE MANUFACTURER'S POLICY. IT WAS REPORTED THE CATHETER WAS USED FOR PCI. DURING PROCEDURE THE IMAGE DISAPPEARED. THE CATHETER/PIM AND PIM/SYSTEM WERE RECONNECTED AND THE CATHETER WAS FLUSHED OUTSIDE THE BODY BUT THE PROBLEM WAS NOT SOLVED. THERE WAS NO PATIENT INJURY. CALCIFICATION: MODERATE THE DEVICE WAS RECEIVED DAMAGED. PER THE FACILITY, THEY DID NOT RECALL THE DEVICE BEING DAMAGED. VISUAL AND MICROSCOPIC INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REVOLUTION CATHETER WAS RECEIVED WITH A SHAFT SEPARATION AT 438MM DISTAL TO THE DISTAL TELESCOPE STRAIN RELIEF AND THE DRIVE CABLE WAS EXPOSED AT THIS LOCATION. THERE WERE ALSO BENDS OBSERVED IN THE PROXIMAL SHAFT OF THE DEVICE. CONTAMINATION IN THE DRIVE CABLE WAS ALSO OBSERVED. SANGUINEOUS MATERIAL WAS PRESENT IN THE DISTAL SHAFT. A CAPACITANCE TEST WAS PERFORMED AND THE DEVICE PASSED WITH A VALUE WITHIN THE EXPECTED RANGE. PER THE MANUFACTURING ENGINEER THIS DEMONSTRATES THAT THE COAXIAL CABLE WAS INTACT BETWEEN THE CONNECTOR AND THE TRANSDUCER, AND THE DEVICE SHOULD HAVE IMAGED. NO ADDITIONAL TESTING BEYOND THE CAPACITANCE TEST WAS ABLE TO BE PERFORMED DUE TO THE SHAFT SEPARATION. THE REPORTED FAILURE OF LOST IMAGE COULD NOT BE DUPLICATED. THIS MDR IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION. THE FACILITY DID NOT RECALL THE DEVICE BEING DAMAGED. DEVICE MANIPULATION, IMPACT AND APPLIED PRESSURE PRIOR TO, DURING OR AFTER USE CAN AFFECT THE INTEGRITY OF THE DEVICE. WE COULD NOT CONCLUSIVELY DETERMINE WHEN OR HOW THE DAMAGE OCCURRED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715559 REVOLUTION 45MHZ IVUS IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 0035 50067144

    Patients

    Seq Age Sex Outcome Treatment
    1