BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1812241 · Received August 16, 2010

    Report

    Report Number
    2024168-2010-01686
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. THE 2.0X20MM VOYAGER (PART 1011392-20, LOT 0060261).

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING DILATATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, AN ATTEMPT WAS MADE TO INFLATE THE VOYAGER BALLOON DILATATION CATHETER USING AN UNSPECIFIED INFLATION DEVICE; HOWEVER, DIFFICULTY WAS EXPERIENCED INFLATING THE BALLOON AND BLOOD CAME BACK INTO THE INFLATION DEVICE. THE DEVICE WAS REMOVED AND ANOTHER ATTEMPT WAS MADE TO DILATE THE VESSEL USING A SECOND VOYAGER BALLOON DILATATION CATHETER; HOWEVER, THE SAME OCCURRED. THE SITE REPORTED THAT BOTH BALLOONS WERE RUPTURED, BUT THE RUPTURES MAY HAVE BEEN CAUSED BY THE INFLATION DEVICE. REPORTEDLY, THE INFLATION GAUGE WAS NOT WORKING; THEREFORE, THE INFLATION PRESSURE COULD NOT BE DETERMINED. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0060361

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR (PART 1011392-20, LOT 0060261)| DILATATION CATHETER: 2.0 X 20MM VOYAGER| INFLATION DEVICE: UNSPECIFIED