BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSSAIL CORONARY DILATION CATHETER

    MDR report key: 1003718 · Received February 19, 2008

    Report

    Report Number
    2024168-2008-00122
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 21, 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 INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE BALLOON MATERIAL COULD HAVE BECOME DAMAGED AS IT WAS ADVANCED ACROSS THE STENT SUCH THAT UPON INFLATION THE BALLOON RUPTURED. NO ADVERSE PATIENT EFFECTS WERE OBSERVED AS A RESULT OF THE BALLOON RUPTURE, A DEFINITE ROOT CAUSE FOR THE BALLOON RUPTURE AND RESISTANCE WITH THE STENT CANNOT 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 TOWARDS PROXIMAL LAD TO FIRST DIAGONAL LAD, ANOTHER COMPANY'S STENT WAS DEPLOYED AS A DIRECT STENTING. THAT CAUSED A SLOW FLOW OF FIRST DIAGONAL LAD. THUS THE CROSSAIL 1.5 X 10 WAS DELIVERED OVER THE DEPLOYED STENT STRUT AND ATTEMPTED TO DILATE FIRST DIAGONAL LAD. AT THE FIRST DILATATION AT 10 ATM, THE BALLOON RUPTURED. IT IS KNOWN THAT WHEN DELIVERING THE CROSSAIL OVER THE DEPLOYED STENT AT PROXIMAL LAD TO FIRST DIAGONAL LAD, THERE WAS RESISTANCE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSSAIL CORONARY DILATION CATHETER 74LOX LOX ABBOTT VASCULAR - CARDIAC THERAPIES NA 6090852

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: RUNTHROUGH| GUIDE CATH: LAUNCHER| STENT: LIBERTE 3.0 X 1 6| DIL CATH: SPRINTER