BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3121951 · Received May 15, 2013

    Report

    Report Number
    3005462046-2013-00026
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K122685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOSCULPT DEVICE GOT STUCK ON THE GUIDE WIRE. THE PHYSICIAN REMOVED THE DEVICE AND THE GUIDE WIRE AS A UNIT AND REWIRED THE LESION TO COMPLETE THE PROCEDURE. THIS RESULTED IN PROLONGATION OF THE PROCEDURE. NO CLINICAL INJURY WAS REPORTED BY THE HOSPITAL. THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE BALLOON HAS NOT BEEN INFLATED. MULTIPLE KINKS WERE OBSERVED ON THE SHAFT POSSIBLE DUE TO HANDLING OF THE DEVICE FOR RETURN TO ANGIOSCORE. DURING FUNCTIONAL TESTING, A 0.014" LABORATORY GUIDE WIRE WAS INSERTED THROUGH THE DISTAL END AND THE LUER WITH NO RESISTANCE OBSERVED. BASED ON THE LAB ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION WAS NOTED.

    Description of Event or Problem · 1

    BALLOON GOT HUNG UP ON THE COMMAND WIRE. DIFFICULT TO ADVANCE, DIDN'T GET ALL THE WAY TO THE LESION AND WAS HARD TO PULL OUT. LOST WIRE POSITION WHEN REMOVING THE BALLOON. PT WAS SUCCESSFULLY TREATED WITH A FOXCROSS BALLOON AND THE CASE ENDED WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215335 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2216-20100 F13010029

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization ABBOTT VASCULAR - COMMAND GUIDE WIRE, 0.014"