BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE WIRE SENSOR

    MDR report key: 451442 · Received March 21, 2003

    Report

    Report Number
    8030904-2003-00003
    Event Type
    Malfunction
    Date Received
    March 21, 2003
    Date of Event
    February 21, 2003
    Report Date
    March 21, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ENTERED VIA ARTERIA BRACHIALIS. THE TARGET VESSEL WAS THE OBTUSE MARGINAL (OM) BRANCH OF THE LEFT CORONARY ARTERY. THE PT, HOWEVER, HAD A DEFORMED SHOULDER (CHEST?). THE PHYSICIAN TRIED TO CROSS PRESSUREWIRE SENSOR BUT THE BEND OF THE OM VESSEL WAS SHARP. REMOVING THE CONNECTOR FROM PRESSUREWIRE SENSOR DID NOT MAKE ANY DIFFERENCE. THE ANGIOCATHETER WAS EXCHANGED BY A GUIDING CATHETER. AFTER RE-EQUALIZING, NO PRESSURE VALUE COULD BE OBTAINED. THE PHYSICIAN EXCHANGED PRESSUREWIRE SENSOR WITH ANOTHER FROM THE SAME LOT. A NEW ATTEMPT WAS MADE BUT PRESSUREWIRE SENSOR BROKE 30CM FROM THE TIP WHEN LOCATED BETWEEN THE #11 AND #13 BRANCHES OF THE OM ARTERY. THE PHYSICIAN INDICATES THAT HE DID NOT TRY TO ENTER OM BRANCH #12. THE BROKEN PRESSUREWIRE SENSOR WAS REMOVED TOGETHER WITH THE CATHETER BY THE AID OF A BALLOON WHICH HELPED PUSH PRESSUREWIRE SENSOR AGAINST THE INNER WALL OF THE GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE WIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12004 D1985

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MACH 1, VL 3.5, 6F.| BOSTON SCIENTIFIC GUIDING CATHETER,