BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER CORONARY DILATATION CATHETER

    MDR report key: 2081787 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03289
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE INDEFLATOR AND VOYAGER CATHETER USED DURING THE PROCEDURE WERE NOT RETURNED, WHICH MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. TO ENSURE THESE DIFFICULTIES ARE NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE ONLINE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER BALLOON DEFLATION. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO INFLATE/DEFLATE A BALLOON CATHETER INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE TO TREAT AN ACUTE MYOCARDIAL INFARCTION PATIENT, IT WAS NOTED THAT INFLATION AND DEFLATION OF THE VOYAGER BALLOON TOOK LONGER THAN NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1