BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1991248 · Received January 28, 2011

    Report

    Report Number
    3005462046-2011-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    November 29, 2007
    Report Date
    November 30, 2007
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO (2) ANGIOSCULPT BALLOONS WERE REPORTED TO HAVE RUPTURED DURING THE PROCEDURE. THIS MDR REFERENCES DEVICE 1 OF 2 FOR A BALLOON RUPTURE THAT OCCURRED AT 18 ATMOSPHERES. REFER TO MDR #3005462046-2011-00003 FOR DEVICE 2 OF 2. DEVICE EVALUATION: DEVICE WAS NOT ANALYZED BECAUSE, AT THE TIME OF THE EVENT, THE INVESTIGATION CONCLUDED THAT THE DEVICE MET ITS PERFORMANCE REQUIREMENTS AND WAS USED BEYOND ITS SPECIFIED RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. RESULTS: THE PROCEDURAL PHYSICIAN INFLATED THE BALLOON ABOVE THE SPECIFIED RATED BURST PRESSURE (RBP). THE PRINTED LABEL INDICATES THAT THE RATED BURST PRESSURE (RBP) IS 14 ATMOSPHERES. CONCLUSIONS: THE DEVICE WAS USED BEYOND ITS SPECIFIED RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. NO FURTHER EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    BALLOONS RUPTURED AT 18 ATMOSPHERES. USED A SECOND ANGIOSCULPT 5.0 X 20 - IT ALSO RUPTURED BUT HAD A GOOD RESULT, ANGIOGRAPHICALLY. THE BURST PRESSURE FOR THE SECOND ANGIOSCULPT DEVICE WAS NOT CLEARLY REPORTED AND CANNOT BE CONFIRMED WHETHER IT ALSO RUPTURED AT 18 ATMOSPHERES. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER LIT ANGIOSCORE, INC. 2076-5020 F07100011

    Patients

    Seq Age Sex Outcome Treatment
    1