BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2620503 · Received June 7, 2012

    Report

    Report Number
    2939520-2012-00036
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE REPORTED DEVICE WAS RECEIVED AND UPON EXAMINATION, IT WAS NOTICED THAT APPROXIMATELY 3.0 CM OF THE DISTAL TIP WAS MISSING. THE MANUFACTURER IS FURTHER INVESTIGATING THIS EVENT FOR ROOT CAUSE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A DIAGNOSTIC CORONARY ANGIO WAS REPORTEDLY PERFORMED. ONE LESION IN THE PROXIMAL LAD WAS FOUND. THE FFR WAS PERFORMED TO VERIFY POSSIBLE STENOSIS. THE FFR (0.78) WAS POSITIVE. PCI WAS PERFORMED AS THE PT HAD TYPICAL ANGINA DURING FFR WITH ADENOSINE. THE FFR WIRE WAS USED AS GUIDING WIRE, THE SECOND GUIDING WIRE WAS PLACED IN FIRST DIAGONAL BRANCH. THERE WAS NO PROBLEM PLACING THE STENT DEVICE OVER THE FFR WIRE. WHEN THE PHYSICIAN TOOK AN IMAGE TO OBSERVE THE RESULT OF STENT IMPLANTATION, IT WAS NOTICED THAT THE FFR WIRE DISTAL TIP WAS NOT MOVING, AND AT THIS POINT THE PHYSICIAN RECOGNIZED THAT THE TIP WAS RAGGED. THE BALLOON CATHETER WAS PULLED OUT AND THE PHYSICIAN SAW THE FFR WIRE WAS STUCK WITH THE CATHETER AND A PORTION OF THE TIP WAS MISSING. THE PHYSICIAN TRIED TO RETRIEVE THE SEPARATED PORTION OF THE TIP WITH DIFFERENT DEVICES. AT THE END, THE PHYSICIAN COULD NOT REMOVE THE TIP AND SENT THE PT TO CBAG SURGERY. THE FFR WIRE DISTAL TIP WAS REMOVED DURING THIS PROCEDURE. THE PT HAD A SINGLE BY PASS IN LAD. AS OF (B)(6) 2012, THE PT WAS IN ICU ON MACHINE VENTILATION (STANDARD AFTER CBAG), AND ALL VITAL PARAMETERS WERE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DQX VOLCANO CORPORATION 8185 114 02738

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR