BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX ESPRIT CORONARY DILATATION CATHETER (PERFUSION)

    MDR report key: 1032290 · Received April 21, 2008

    Report

    Report Number
    2024168-2008-00328
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 24, 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, LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. THE LESION WAS MODERATELY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. ALSO, THE ESPRIT WAS USED TO EXPAND A STENT, WHICH HAD NOT FULLY DEPLOYED, WHICH SUGGESTS THAT THE STENT STRUTS COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. HOWEVER, 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 PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED AND ANOTHER COMPANY'S STENT WAS PRESSURIZED TO DEPLOY. WHEN THE PRESSURE REACHED 10 ATM, A PERFORATION OCCURRED. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE ESPRIT WAS ENGAGED FOR HEMOSTASIS. DURING THE FIRST INFLATION, THE BALLOON OF THE ESPRIT RUPTURED AT 6 ATM. IT WAS REPLACED BY ANOTHER COMPANY'S BALLOON. THE PATIENT WAS TRANSFERRED TO SURGERY TO TREAT THE PERFORATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX ESPRIT CORONARY DILATATION CATHETER (PERFUSION) LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6042051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT CYPHER 2.5X18| DIL CATH: VENT 2.0X15| PRESTIGE 3.5X20