BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTWIRE II PRESSURE GUIDE WIRE

    MDR report key: 2093296 · Received April 15, 2011

    Report

    Report Number
    2939520-2011-00025
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER; THEREFORE, A DEVICE EVALUATION HAS NOT YET BEEN PERFORMED. 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 THIS FAILURE MODE WITHIN THIS LOT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE WIRE WAS KINKED WHEN THE PHYSICIAN WAS HANDLING THE WIRE IN THE ARTERY. THE SECOND WIRE FUNCTIONED AS INTENDED AND ACCOMPLISHED THE FFR PROCEDURE. FURTHER INFORMATION WAS OBTAINED AND THE PHYSICIAN INDICATED THAT THERE WAS NO DAMAGE TO THE WIRE PRIOR TO THE INSERTION INTO THE PATIENT'S BODY. THE WIRE WAS TRAPPED AT STENT OR CALCIFICATION IN THE LESION AND THE PHYSICIAN FELT RESISTANCE BUT THE WIRE DID NOT GET STUCK. THERE WAS NO INTERVENTION PERFORMED AND NO ADVERSE EVENT OR PATIENT INJURY OCCURRED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTWIRE II PRESSURE GUIDE WIRE CATHETER TIP PRESSURE TRANSDUCER DXO VOLCANO CORPORATION 6600 040 03096

    Patients

    Seq Age Sex Outcome Treatment
    1