BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (TM)

    MDR report key: 2181845 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03012
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE TRANSRADIAL ARTERY. THE LESION WAS 90% STENOSED WITH CALCIFICATION. THE LESION WAS NOT PRE-DILATED. A 4.00 X 12MM VERIFLEX STENT DELIVERY SYSTEM WAS SELECTED AND WHILE ADVANCING TO THE LESION RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN WAS UNABLE TO CROSS THE TARGET LESION. UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893412400 12156470

    Patients

    Seq Age Sex Outcome Treatment
    1