BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1000249 · Received February 14, 2008

    Report

    Report Number
    2024168-2008-00111
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 12, 2008
    Report Date
    January 15, 2008
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE LESION BEING TREATED IN THIS PROCEDURE WAS MILDLY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO MECHANICALLY DAMAGING THE BALLOON SURFACE SUCH THAT UPON INFLATION, THE BALLOON RUPTURED. HOWEVER, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A ROOT CAUSE FOR THE BALLOON RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT A 95% STENOSIS WAS OBSERVED IN THE PROXIMAL-MID LAD WITH MILD CALCIFICATION AND MILD TORTUOSITY. DURING THE SECOND INFLATION, THE BALLOON OF THE VOYAGER RUPTURED AT 12 ATM. ANOTHER COMPANY'S BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER 74LOX LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7040233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK