BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2133648 · Received June 8, 2011

    Report

    Report Number
    3005462046-2011-00023
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED IS THE EVENT DESCRIPTION AS REPORTED IN THE CATHETERIZATION REPORT, WHICH WAS PROVIDED BY THE HOSPITAL. THE PROCEDURAL ANGIOGRAM WAS ALSO REQUESTED BUT NOT PROVIDED BY THE HOSPITAL. METHOD: PRODUCT DISPOSED BY HOSPITAL, THUS UNABLE TO EVALUATE DEVICE. RESULTS: CORONARY ARTERY DISSECTION IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE IN THE ANGIOSCULPT DEVICE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    A 2.0 X 10 ANGIOSCULPT WAS USED TO SCORE/PRE-DILATE THE OSTIUM OF OM2. THE CLINICIAN INFLATED THE ANGIOSCULPT SLOWLY, PER THE MANUFACTURER'S RECOMMENDATIONS, FOR APPROXIMATELY A TOTAL OF ONE (1) MINUTE. POST-SCORING ANGIOGRAPHY REVEALED A DISSECTION OF THE OSTIAL OM2. AS A RESULT OF THIS, THE CLINICIAN DECIDED TO STENT INTO THE OM2 ACROSS THE TRUE AV GROOVE CIRCUMFLEX. THE OSTIUM OF THE TRUE AV GROOVE CIRCUMFLEX WAS PRE-DILATED WITH A 3.0 X 12 COMPLIANT BALLOON WITH EXCELLENT RESULTS. A 3.0 X 22 INTEGRITY BARE-METAL STENT WAS DEPLOYED AT 14 ATMOSPHERES FOR 30 SECONDS. THE FINAL ANGIOGRAPHIC RESULTS WERE EXCELLENT. PT IS CLINICALLY STABLE. NO ANGIOGRAPHIC COMPLICATIONS. SUCCESSFUL PCI OF COMPLICATED OM/LEFT CIRCUMFLEX BIFURCATION WITH STENT PLACEMENT (3.0 X 22 INTEGRITY BARE-METAL) IN THE OM2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2010 F11010031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention WIRE| ABBOTT HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) GUIDE| ABBOTT ASAHI PROWATER CORONARY GUIDE WIRE