BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1872717 · Received October 8, 2010

    Report

    Report Number
    3005462046-2010-00008
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K101735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL EXAMINATION OF THE RETURNED CATHETER FOUND THAT THE DISTAL SECTION OF THE SCORING ELEMENT RING WAS MANGLED AND INVERTED AND THERE WAS A FRACTURE OF A SINGLE SCORING ELEMENT STRUT AT THE SCORING ELEMENT RING SECTION. THERE WAS EVIDENCE OF BOND DISRUPTION AND DISPLACEMENT, AS WELL AS NECKING AND STRETCHING ON THE DISTAL CATHETER SHAFT. ADDITIONAL MANUFACTURER NARRATIVE: THE PRODUCT PROBLEM WAS OBSERVED AFTER THE CATHETER WAS WITHDRAWN. THIS IS THE FIRST OBSERVED OCCURENCE OF THIS TYPE.

    Description of Event or Problem · 1

    THE ANGIOSCULPT WAS APPLIED FOR THE STENOTIC LESION FOUND IN ARTERIOVENOUS ANASTOMOSIS IN HEMODIALYSIS SHUNT. ITS DEGREE OF STENOSIS WAS 85%. THE LESION WAS DILATED FOUR TIMES BY THE ANGIOSCULPT. THE PHYSICIAN CONDUCTED THE DILATIONS AT 8 ATMOSPHERES FOR THE FIRST, AND 14 ATMOSPHERES FOR THE SECOND, THIRD AND FOURTH DILATION. AS A RESULT, THE STENOSIS WAS DILATED SUFFICIENTLY. THUS THE PHYSICIAN RETRIEVED THE ANGIOSCULPT. AFTER THE RETRIEVAL, HE RECOGNIZED A PEELING OF THE MATERIAL IN THE DISTAL TIP OF THE ANGIOSCULPT. THE PROCEDURE WAS FINISHED SUCCESSFULLY AND NO ADVERSE EVENT WAS SEEN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER LIT ANGIOSCORE, INC. 2039-3520 F10040003

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR