BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1220842 · Received October 30, 2008

    Report

    Report Number
    2024168-2008-01030
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, MATERIALS, LESION CALCIFICATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS INSTANCE, THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED DURING INTERACTIONS WITH OTHER DEVICES, OR THE CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. IT SHOULD BE NOTED THAT THE RX VOYAGER'S IFU WARNS THAT "BALLOON PRESSURE SHOULD NOT EXCEED THE RBP." UNFORTUNATELY, WITHOUT THE RETURNED DEVICE FOR ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION ON A BEND IN THE DISTAL RCA. WHEN THE DEVICE WAS PRESSURIZED TO 16 ATM, THE BALLOON RUPTURED. THERE WERE NO PT EFFECTS REPORTED. 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 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6101231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK