BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY OPTIMA STEERABLE, 1110-7-7-SM-OPT25

    MDR report key: 2121047 · Received June 9, 2011

    Report

    Report Number
    2030404-2011-00172
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALED THE CATHETER WAS REC'D IN TWO PIECES. THE CATHETER SHAFT WAS CUT AT THE DISTAL END OF THE HANDLE. THE CATHETER SHAFT WAS TOTALLY SEPARATED FROM THE HANDLE. THERE WAS A WHITE STRETCH MARK 5.5 CM FROM THE LOOP PLANE. THE CATHETER TIP WAS INSPECTED UNDER THE MICROSCOPE, AND THERE WERE NO ANOMALIES OBSERVED. FUNCTIONAL TESTING OF THE CATHETER WAS NOT POSSIBLE DUE TO THE CATHETER BEING CUT. INVESTIGATION CONFIRMED THE REPORT THAT THE CATHETER HAD BEEN CUT, NO OTHER ANOMALIES NOTED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING AN ELECTROPHYSIOLOGICAL PROCEDURE THE INQUIRY OPTIMA CATHETER BECAME ENTANGLED IN THE CHORDAE TENDINEAE. THE PHYSICIAN WAS MANEUVERING THE INQUIRY OPTIMA CATHETER IN THE LEFT VENTRICLE DURING AN ELECTROPHYSIOLOGICAL PROCEDURE WHEN THE INQUIRY OPTIMA CATHETER BECAME TANGLED IN THE CHORDATE TENDINEAE. THE PHYSICIAN CUT THE CATHETER AT THE DISTAL END OF THE CATHETER HANDLE AND UTILIZED A LONG INTRODUCER TO REMOVE THE ENTANGLED CATHETER SHEATH FROM THE CHORDATE TENDINEAE. THE PHYSICIAN REPORTED THERE WERE NOT ANY ISSUES WITH THE CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY OPTIMA STEERABLE, 1110-7-7-SM-OPT25 DIAGNOSTIC INTRAVASCULAR CATHETER DRF ST. JUDE MEDICAL, IRVINE 81687 3223000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR