BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1060976 · Received June 12, 2008

    Report

    Report Number
    2024168-2008-00481
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED INCIDENT INFO. FACTORS THAT CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MFG, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREP PRIOR TO USE. IN THIS CASE, THE HEAVILY CALCIFIED LESION COULD HAVE CONTRIBUTED TO MECHANICALLY DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION, IT RUPTURED. FURTHERMORE, THREE OTHER DILATATION CATHETERS RUPTURED DURING THE PROCEDURE, SUGGESTING THAT THE LESION CHARACTERISTICS CONTRIBUTED TO THE RUPTURE. HOWEVER, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A DEFINITE ROOT CAUSE CAN NOT 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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE OBTUSE MARGINAL. THREE OF ANOTHER CO'S BALLOONS RUPTURED WHILE TRYING TO OPEN UP THE LESION. THE 2.5 X 15 MM VOYAGER ALSO RUPTURED WHEN INFLATED TO 9 ATM. TWO NON-COMPLIANT BALLOONS WERE UNABLE TO COMPLETELY CROSS THE LESION, BUT WERE INFLATED IN AN ATTEMPT TO PARTIALLY OPEN THE LESION. THE RESULTS WERE SUBOPTIMAL. NO PT EFFECTS WERE REPORTED. NO ADD'L 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 8020641

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR QUANTUM (X2)| DILATATION CATHETER: MAVERICK (X3)