BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 4152313 · Received October 3, 2014

    Report

    Report Number
    3005462046-2014-00029
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K122685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOSCULPT DEVICE IS BEING REPORTED FOR A PRODUCT PROBLEM DUE TO THE EXCESSIVE DEFLATION TIME. THE ANGIOSCULPT WAS DISPOSED BY THE HOSPITAL, THUS, NO EVALUATION PERFORMED.

    Description of Event or Problem · 1

    AFTER THE ANGIOSCULPT WAS INFLATED, IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON. AFTER ABOUT 10 MINUTES AND MULTIPLE ATTEMPTS TO DEFLATE, THE BALLOON FINALLY DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617355 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL LIT ANGIOSCORE, INC. 2216-30100 F14030001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 0.014" GUIDE WIRE: MANUFACTURER UNK| 6F INTRODUCER SHEATH: MANUFACTURER UNK