BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 796794 · Received December 11, 2006

    Report

    Report Number
    6000093-2006-02580
    Event Type
    Malfunction
    Date Received
    December 11, 2006
    Date of Event
    November 12, 2006
    Report Date
    November 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE DELIVERY DEVICE WITH THE STENT ON THE BALLOON WAS REC'D AND DAMAGE WAS OBSERVED ON THE STENT. VISUAL EXAMINATION OF THE STENT REVEALED DAMAGE TO THE PROXIMAL END. THE PROXIMAL STENT STRUTS WERE BENT. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO VISUAL DEFECTS WERE OBSERVED UNDER MAGNIFICATION. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. THERE IS NO EVIDENCE THAT THE DEVICE WAS IMPROPERLY MANUFACTURED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8792279 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE ROOT CAUSE OF THE STENT DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE LIBERTE STENT WAS FOUND TO BE DAMAGED. THE CUSTOMER REPORTED THAT "WHEN REMOVING THE 2.5X20 LIBERTE STENT FROM THE SHEATH DURING PREPARATION, WHEN REVIEWING THE STENT BODY IT WAS NOTICED THAT THERE WAS SOMETHING PROTRUDING THAT COULD BE DETECTED BY TACT." THIS DEVICE WAS NEVER USED ON THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES, AND THE PT'S STATUS WAS REPORTED AS 'OKAY.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORP. NA 8792279

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR