BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)

    MDR report key: 1972528 · Received December 30, 2010

    Report

    Report Number
    3005462046-2010-00032
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    September 29, 2009
    Report Date
    September 30, 2009
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER SHAFT SEPARATION OCCURRED AND WAS DETECTED PRIOR TO USE IN PT AND THE CATHETER WAS NOT USED IN A PT. THUS, THERE WAS NO PT INVOLVEMENT. FOREIGN: COUNTRY OF ORIGIN IS (B)(6). EVAL SUMMARY: VISUAL EXAMINATION OF THE RETURNED CATHETER FOUND THAT THE CATHETER SHAFT SEPARATED AT THE HYPOTUBE APPROX 13 CM FROM THE DISTAL END OF THE STRAIN RELIEF. THE SEPARATED END APPEARED BENT.

    Description of Event or Problem · 1

    DEVICE WAS REMOVED FROM THE PACKAGING, ONE HAND TOUCHED THE HUB AND THE OTHER HAND TOUCHED THE SHAFT OF THE CATHETER. AT THE SAME TIME, THE DEVICE FRACTURED WITHOUT NOTICEABLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) NWX ANGIOSCORE, INC. 2001-2515 G08080007

    Patients

    Seq Age Sex Outcome Treatment
    1