BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1991184 · Received January 28, 2011

    Report

    Report Number
    3005462046-2011-00003
    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 2 OF 2, WHEREIN THE BURST PRESSURE FOR THE SECOND ANGIOSCULPT DEVICE WAS NOT CLEARLY REPORTED AND CANNOT BE CONFIRMED WHETHER IT ALSO RUPTURED AT 18 ATMOSPHERES. REFER TO MDR #3005462046-2011-00002 FOR DEVICE 1 OF 2 FOR A BALLOON RUPTURE THAT OCCURRED AT 18 ATMOSPHERES. DEVICE EVALUATION: THE INVESTIGATION CONCLUDED THAT THE FIRST DEVICE USED MET ITS PERFORMANCE REQUIREMENTS AND RUPTURED ABOVE ITS SPECIFIED RATE BURST PRESSURE. EVALUATION WAS NOT DETERMINED TO BE REQUIRED FOR EITHER DEVICE. THE BURST PRESSURE FOR THE SECOND ANGIOSCULPT DEVICE WAS NOT CLEARLY REPORTED AND CANNOT BE CONFIRMED WHETHER IT ALSO RUPTURED AT 18 ATMOSPHERES. CONCLUSIONS: THE BURST PRESSURE FOR THE SECOND ANGIOSCULPT DEVICE WAS NOT CLEARLY REPORTED AND CANNOT BE CONFIRMED WHETHER IT ALSO RUPTURED AT 18 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