BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)

    MDR report key: 1082059 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00593
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 23, 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. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE TARGET LESION CONTAINED 99% STENOSES, RESTENOSIS AND MILD CALCIFICATION, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR IN THIS CASE. THE RUPTURE OCCURRED DURING THE SECOND INFLATION, WHICH SUGGESTS THAT IT MAY BE A RESULT OF CIRCUMSTANCES OF THE PROCEDURE. UNFORTUNATELY, WITHOUT THE DEVICE TO EXAMINE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE COULD 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 BALLOON RUPTURED DURING A SECOND INFLATION AT 10 ATM. REPORTEDLY, THERE WAS NO PT INJURY. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6071251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK