BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3180075 · Received June 13, 2013

    Report

    Report Number
    3005462046-2013-00032
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K112182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT IS UNKNOWN. ATTEMPTS TO OBTAIN THE INFORMATION HAS NOT BEEN SUCCESSFUL. THE ANGIOSCULPT DEVICE WAS RETURNED IN TWO PIECES FOR LAB ANALYSIS. THE BALLOON SEPARATED FROM THE SHAFT AND WAS STUCK IN THE INTRODUCER SHEATH. THE INNER MEMBER AND SHAFT WERE RETURNED INTACT TO THE GUIDE WIRE. THE BALLOON AND THE PROXIMAL BOND WERE DAMAGED AND SLIGHT LIFTING OF THE DISTAL BOND OVERFLOW WAS OBSERVED. THE INNER MEMBER SEPARATED AT THE DISTAL BOND AND THE SHAFT IS ACCORDION IN MULTIPLE LOCATIONS. THE BALLOON WAS REMOVED FROM THE INTRODUCER SHEATH AND FOUND THE TRANSITION TUBING, SCORING ELEMENT, AND A PORTION OF THE SHAFT WERE INSIDE THE INTRODUCER SHEATH. THE MARKER BANDS WERE DISPLACED. THE DISTAL MARKER BAND WAS LOCATED NEAR THE DISTAL BOND AND THE PROXIMAL MARKER BAND WAS LOCATED NEAR THE PROXIMAL BOND. ALL PIECES OF THE ANGIOSCULPT DEVICE WERE ACCOUNTED FOR. BASED ON THE LAB ANALYSIS, THE ACCORDION OF THE SHAFT AT MULTIPLE LOCATIONS SUGGESTS THAT THE DEVICE EXPERIENCED EXCESSIVE EXERTION OF FORCE APPLIED BY THE USER, WHICH LED TO THE SEPARATION OF THE ANGIOSCULPT DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ANGIOSCULPT CATHETER, RETAINED DEVICE COMPONENTS IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    AFTER 6 TO 8 INFLATIONS, THE DEVICE COULD NOT BE FULLY WITHDRAWN INTO THE 6F SHEATH. PHYSICIAN REMOVED ENTIRE SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE ANGIOSCULPT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269736 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2237-50100 F13010043

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR J-TIP GUIDEWIRE, 0.014"| COOK MEDICAL FLEXOR INTRODUCER, 6FR| BOSTON SCIENTIFIC PT2 LIGHT SUPPORT