BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)

    MDR report key: 1163382 · Received September 10, 2008

    Report

    Report Number
    2024168-2008-00783
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 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 - FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, THE LESION WAS MODERATELY CALCIFIED WITH 90% STENOSIS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES EXPERIENCED. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. UNFORTUNATELY, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A CONCLUSIVE 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 RX ESPRIT BALLOON RUPTURED DURING THE FIRST INFLATION AT 4 ATM. A STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE IN THIS CASE. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. 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 CATHETERS (PERFUSION) LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6090551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: TAXUS| GUIDE WIRE: RUNTHROUGH| GUIDE CATH: MACH1 6F FR4