BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1925362 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02730
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTIONS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE RX VOYAGER INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE 3.5 X 18 MM MULTI-LINK RX VISION (1007849-18/0071941), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREDILATATION OF A LESION WITH AN RX VOYAGER IN THE MID CIRCUMFLEX ARTERY, A DISSECTION OCCURRED. THE RX VISION STENT WAS SELECTED FOR TREATMENT AND WAS PREPPED FOR USE. THE STENT WAS ON THE BALLOON PRIOR TO THE REMOVAL OF THE STYLET. THE STENT DELIVERY SYSTEM WAS ADVANCED IN THE PATIENT AND WAS DEPLOYED; HOWEVER, AFTER DEPLOYMENT THE STENT COULD NOT BE SEEN ON ANGIOGRAPHY. A SEARCH FOR THE STENT FOUND IT LOCATED ON THE STYLET ON THE BACK TABLE. ANOTHER RX VISION STENT OF THE SAME SIZE WAS USED FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0062461

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention