BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE (R) SENSOR

    MDR report key: 795929 · Received December 14, 2006

    Report

    Report Number
    8030904-2006-00002
    Event Type
    Injury
    Date Received
    December 14, 2006
    Date of Event
    November 21, 2006
    Report Date
    December 13, 2006
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PW WAS USED TOGETHER WITH A RANGE OF OTHER DEVICES DURING THE DESCRIBED PROCEDURE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DESCRIBED INCIDENT IS A KNOWN RISK WITH CATHETERIZATION PROCEDURE AND IS ADDRESSED AS A POSSIBLE ADVERSE EVENT IN THE INSTRUCTIONS FOR USE. THE EVENT DESCRIPTION DOES NOT INDICATE ANY MALFUNCTION.

    Description of Event or Problem · 1

    DURING NORMAL CATHETERIZATION PROCEDURE OF A FEMALE THE FOLLOWING WAS REPORTED: "ATTEMPTED PW OF MID-LAD. VERY TORTUOUS VESSEL. DISSECTION PROXIMAL TO LESION OCCURRED. PW REMOVED. ATTEMPTED TO RE-CROSS FOR APPROX 30 MINS. FINALLY SUCCESSFUL WITH PRO-WATER FLEX WIRE. THEN INTRODUCED PILOT 50 GUIDEWIRE. ATTEMPTED PTCA OF DISSECTION WITH MAVERICK BALLOON. SPIRAL DISSECTION THEN OCCURRED. ATTEMPTED TO PLACE JOSTENT (UNSUCCESSFUL). TAXUS STENT PLACED PROXIMAL IN HOPES OF IMPROVING LUMEN ACCESS. PERFORATION THEN OCCURRED. PATIENT WENT EMERGENCY TO OR." COMMENT: PW=PRESSUREWIRE SENSOR FROM RADI MEDICAL SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE (R) SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention MAVERICK BALLOON| JOSTENT| TAXUS STENT| PILOT 50 GUIDEWIRE| PRO-WATER FLEX WIRE