BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK PTA DILATATION CATHETER

    MDR report key: 2605226 · Received June 8, 2012

    Report

    Report Number
    1016427-2012-00080
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    November 16, 2011
    Report Date
    December 22, 2011
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD
    Product Code
    LIT
    PMA / PMN Number
    K102035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A BALLOON ANGIOPLASTY OF THE LEFT LEG, AT THE TIME THE BALLOON WAS DEFLATED TO BE WITHDRAWN, THE TIP OF THE BALLOON CATHETER BROKE OFF. ALL BROKEN PARTS WERE ABLE TO BE RETRIEVED WITH THE EXCEPTION OF THE SMALL METALLIC MARKER TIP. THE MANUFACTURING DOCUMENTATION FOR LOT: 50 32729 WERE REVIEWED AND NO ANOMALIES WERE DETECTED. THIS LOT NUMBER HAS NOT BEEN ASSOCIATED WITH ANY OTHER CUSTOMER COMPLAINTS. WITH THE LIMITED INFORMATION AVAILABLE, AND NO PRODUCT RETURN, THE COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS TO THE FAILURE REPORTED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. AFTER AN INTERNAL REVIEW OF OUR CURRENT QUALITY AGREEMENTS WITH OUR EXTERNAL MANUFACTURING PARTNERS IT WAS DETERMINED THAT CORDIS IS CONSIDERED THE LEGAL IMPORTER OF THIS DEVICE. THEREFORE, THE REGULATORY REPORT IS BEING FILED ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A BALLOON ANGIOPLASTY OF THE LEFT LEG, AT THE TIME THE BALLOON WAS DEFLATED TO BE WITHDRAWN, THE TIP OF THE BALLOON CATHETER BROKE OFF. ALL BROKEN PARTS WERE ABLE TO BE RETRIEVED WITH THE EXCEPTION OF THE SMALL METALLIC MARKER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK PTA DILATATION CATHETER PTA CATHETERS LIT CLEARSTREAM TECHNOLOGIES LTD 50032729

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention