BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1082851 · Received July 25, 2008

    Report

    Report Number
    2024168-2008-00608
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- THERE ARE SEVERAL FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE SUCH AS BALLOON DAMAGE DURING MANUFACTURING INTERACTION WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR EXCEEDING RATED BURST PRESSURE (RBP). THE LESION CHARACTERISTICS WERE NOT PROVIDED, SO IT IS NOT CLEAR HOW THESE FACTORS MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE. WITHOUT THE DEVICE TO EXAMINE, A THOROUGH ANALYSIS COULD NOT BE PERFORMED AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED DISCREPANCY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE VOYAGER BALLOON CATHETER WAS PRESSURIZED TO 12 ATM, THE BALLOON RUPTURED. 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 LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7062531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFLATION: MEDTRONIC