BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3962695 · Received June 19, 2014

    Report

    Report Number
    3005462046-2014-00021
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K100303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURST PRESSURE FOR THE ANGIOSCULPT DEVICE WAS NOT REPORTED. IT IS UNK IF THE DEVICE BURST ABOVE THE RATED BURST PRESSURE (RBP) OF 14 ATM. AS A CONSERVATIVE MEASURE, AN MDR IS BEING SUBMITTED IN ABUNDANCE OF CAUTION. THE ANGIOSCULPT DEVICE WAS DISPOSED BY THE HOSP, THUS NO EVAL PERFORMED.

    Description of Event or Problem · 1

    THE ANGIOSCULPT DEVICE WAS PREPPED NORMALLY. THE DEVICE WAS INSERTED INTO THE PT OVER THE GUIDE WIRE IN NORMAL FASHION. UPON INFLATION, THE BALLOON PORTION OF THE DEVICE BURST (UNK PRESSURE). THE DEVICE WAS REMOVED INTACT. ANOTHER ANGIOSCULPT DEVICE WAS USED TO SUCCESSFULLY TREAT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359390 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL LIT ANGIOSCORE, INC. 2076-5040 F12070014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 6F INTRODUCER SHEATH -MANUFACTURERS UNK| 0.014" GUIDE WIRE