BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    MDR report key: 1000247 · Received February 14, 2008

    Report

    Report Number
    2024168-2008-00108
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MCX
    PMA / PMN Number
    P890043
    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. BALLOON RUPTURES MAY OCCUR DUE TO, BUT NOT LIMITED TO, MANUFACTURING ISSUES, MATERIALS, MECHANICAL DAMAGE, HANDLING OF THE DEVICE DURING USE, OVER INFLATION AND/OR INTERACTION WITH PATIENT ANATOMY OR INTERACTION WITH ASSOCIATIVE DEVICES. IN THIS INSTANCE, IT WAS REPORTED THAT THE TARGET LESION HAD MILD CALCIFICATION WITH 90% STENOSIS WHICH MAY HAVE CONTRIBUTED TO THE RUPTURE. SINCE THE DEVICE WAS ABLE TO BE PREPARED FOR USE, THE RUPTURE APPEARS TO BE RELATED TO THE CIRCUMSTANCES DURING THE PROCEDURE; HOWEVER, WITHOUT THE DEVICE TO ANALYZE A 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 PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE FLEXI-CUT BALLOON RUPTURED AT 3 ATM AT THE FIRST INFLATION. ANOTHER FLEXI-CUT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM 74MCX MCX ABBOTT VASCULAR-CARDIAC THERAPIES NA 6071951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ATHERECTOMY DEVICE: FLEXI-CUT| GUIDE WIRE: GRAND SLAM| GUIDE CATH: MACH 1 FCL 4.0| OTHER: IVUS GALLAXY 2