BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    MDR report key: 1000252 · Received February 14, 2008

    Report

    Report Number
    2024168-2008-00103
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 16, 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 CONCLUSIONS SUMMATION: BALLOON RUPTURES MAY OCCUR DUE TO, BUT NOT LIMITED TO, MFG ISSUES, MATERIALS, MECHANICAL DAMAGE, HANDLING OF THE DEVICE DURING USE, OVER INFLATION AND/OR INTERACTION WITH PT ANATOMY OR INTERACTION WITH ASSOCIATED DEVICES. IT WAS REPORTED THAT THE LESION WAS CALCIFIED, 75% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE FAILURE. SINCE THE DEVICES WERE ABLE TO BE PREPPED FOR USE, AND USED FOR SEVERAL CUTS, THIS FAILURE APPEARS TO BE RELATED TO THE CIRCUMSTANCES DURING THE PROCEDURE; HOWEVER, WITHOUT THE DEVICES TO ANALYZE A ROOT CAUSE FOR THE REPORTED DISCREPANCY CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION HAD NO TORTUOSITY, WAS MODERATELY CALCIFIED, ECCENTRIC, AND HAD 75% STENOSIS. ANOTHER COMPANY'S GUIDE WIRE WAS DELIVERED FROM THE LAD TOWARDS THE LESION. THE LESION WAS CHECKED WITH THE IVUS, AND FOUND THAT THERE WAS MILD CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH ANOTHER COMPANY'S BALLOON CATHETER. THEN THE FLEXI-CUT WAS DELIVERED AND AFTER THREE TO FOUR CUTS, THE BALLOON RUPTURED AT 30 PSI. A SECOND FLEXI-CUT WAS SELECTED AND THE DCA WAS CONTINUED, HOWEVER, AT THE SECOND CUT, THE BALLOON ALSO RUPTURED. NO ADDITIONAL EVENT OR PT INFO 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 6040151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: GRANDSLAM GUIDE CATH:MACH1 ICL 4.0| DIL CATH: LACROSSE| OTHER: GALAXY II| FLEXI-CUT (PART # 1003094-400)