BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE CERTUS

    MDR report key: 1812353 · Received August 16, 2010

    Report

    Report Number
    8030904-2010-00003
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 16, 2010
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXO
    PMA / PMN Number
    K080813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, WE WERE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. WE DO NOT BELIEVE THAT THERE IS ANY EVIDENCE OF A DEVICE MALFUNCTION OR ANY DEFICIENCY WITH THE INSTRUCTION FOR USE REQUIRING CORRECTIVE ACTION. WE WILL CONTINUE TO CLOSELY MONITOR THE PERFORMANCE OF THIS PRODUCT FOR ANY SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRESSUREWIRE WAS USED FOR FFR MEASUREMENT ON A PATIENT WITH A BORDERLINE LESION ON THE PROXIMAL LAD. DURING THE SECOND IC BOLUS INJECTION OF ADENOSINE, THE PHYSICIAN DISCOVERED THAT THERE WAS A VESSEL DISSECTION ON THE PROXIMAL LAD. PATIENT WAS SUBSEQUENTLY STENTED AND STABILIZED IN THE CATHLAB. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE CERTUS GUIDEWIRE SENSOR DXO RADI MEDICAL SYSTEMS AB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention