BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1003763 · Received February 22, 2008

    Report

    Report Number
    2024168-2008-00129
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 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

    (B)(4). 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 MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE LESION TREATED DURING THE PROCEDURE WAS MODERATELY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO DAMAGING THE SURFACE OF THE BALLOON. IT IS POSSIBLE THAT THE STRUTS OF THE STENT IMPLANT COULD HAVE CONTRIBUTED TO THE RUPTURE. WITHOUT A RETURNED DEVICE FOR ANALYSIS, A DEFINITE 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 THE LESION WAS MODERATELY CALCIFIED IN THE PROXIMAL LAD. AFTER DEPLOYING ANOTHER COMPANY'S STENT, THE VOYAGER WAS INFLATED FOR POST-DILATATION. DURING THE INFLATION, THE BALLOON RUPTURED DUE TO THE CALCIFICATION. ANOTHER COMPANY'S BALLOON 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 7042731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK