BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 5234700 · Received November 18, 2015

    Report

    Report Number
    3005462046-2015-00029
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    ANGIOSCORE, INC
    Product Code
    LIT
    PMA / PMN Number
    K142983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE BALLOON HAD BEEN INFLATED. THE SHAFT WAS KINKED NEAR THE PROXIMAL END POSSIBLY DUE TO HANDLING FOR RETURN. DURING FUNCTIONAL TESTING, A 0.014" GUIDE WIRE WAS INSERTED THROUGH THE DISTAL END WITH NO ISSUES. THE BALLOON WAS INFLATED AND DEFLATED MULTIPLE TIMES AND WAS ABLE TO HOLD PRESSURE. BLOOD WAS PRESENT IN THE BALLOON; HOWEVER, NO LEAKS WERE OBSERVED ON THE CATHETER. BASED ON THE LAB ANALYSIS, THE BALLOON WAS ABLE TO HOLD PRESSURE WITH NO LEAKS OBSERVED THROUGHOUT THE WHOLE LENGTH OF THE CATHETER. THUS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE 510(K) NUMBER FROM K112182 TO K142983.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE AT TIME OF EVENT OR DOB AND WEIGHT ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE BALLOON RUPTURED WHEN THE PHYSICIAN INFLATED THE BALLOON ABOVE THE RBP OF 14 ATM. RECURRENCE OF THE MALFUNCTION COULD RESULT IN A VESSEL DISSECTION REQUIRING POSSIBLE STENT PLACEMENT. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE ANGIOSCULPT DEVICE HAD NOT BEEN RETURNED, THUS NO EVALUATION PERFORMED. THE ANGIOSCULPT DEVICE WAS USED OFF-LABEL. THE IFU STATES THE BALLOON PRESSURE SHOULD NOT EXCEED THE RBP (14 ATM).

    Description of Event or Problem · 1

    AT INITIAL INFLATION, THE ANGIOSCULPT BALLOON RUPTURED BETWEEN 16-18 ATMS. THE RATED BURST PRESSURE (RBP) IS 14 ATM. THE TECH SAW BLOOD BACK IN THE INFLATION DEVICE. THE ANGIOSCULPT WAS SAFELY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763279 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL LIT ANGIOSCORE, INC 2237-60100 F15030013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other