BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2033997 · Received March 18, 2011

    Report

    Report Number
    3005462046-2011-00011
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DISPOSED BY HOSP AND LOT NUMBER NOT PROVIDED, THUS CANNOT OBTAIN EXP. DATE AND DEVICE MFR. DATE. METHOD: PRODUCT DISPOSED BY HOSP, THUS UNABLE TO EVALUATE DEVICE. RESULTS: THE PROCEDURAL PHYSICIAN REPORTED THAT THE VESSEL PERFORATION WAS PROBABLY A RESULT OF THE LESION CALCIFICATION. ADDITIONALLY, THE TREATED VESSEL REPORTEDLY HAD SEVERAL STENTS IN PLACE, AS WELL AS OVER-LAPPING OF THE STENTS, PRIOR TO THE PROCEDURE. THE PERFORATION REPORTEDLY OCCURRED IN A SEGMENT OF THE VESSEL THAT HAD OVER-LAPPED STENTS. CORONARY ARTERY PERFORATION IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE IN THE ANGIOSCULPT INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED: THE CLINICIAN DELIVERED A 2.5 X 10 MM ANGIOSCULPT INTO AN IN-STENT RESTENOSIS IN THE DISTAL LAD AND INFLATED THE BALLOON TO 10 ATMOSPHERES. THERE WAS A VESSEL PERFORATION IN THE OVER-LAPPED STENT SEGMENT. THE CLINICIAN STOPPED THE PROCEDURE. ADDITIONAL INFO RECEIVED: THE VESSEL ALREADY HAD SEVERAL STENTS IN PLACE FROM PRIOR PROCEDURES AS WELL AS OVER-LAPPING OF THE STENTS. THE VESSEL PERFORATED AT THE OVER-LAPPED STENT PORTION IN THE DISTAL LAD AFTER ANGIOSCULPT INFLATION. THERE WERE NO OTHER DEVICES USED OR IMPLANTED. THE BLOOD FROM THE LAD THAT EXITED THE PERFORATION SITE EMPTIED INTO THE RIGHT VENTRICLE, THEREFORE BEING RE-CIRCULATED IN THE BODY. NO OTHER RESOLUTION WAS NECESSARY. THE PT REMAINED STABLE AT ALL TIMES. UPON F/U, THE PROCEDURAL PHYSICIAN REPORTED THAT HE DID NOT FEEL THE VESSEL PERFORATION WAS A RESULT OF THE ANGIOSCULPT DEVICE AND THAT IT WAS PROBABLY A RESULT OF THE LESION CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other