BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)

    MDR report key: 3760862 · Received April 7, 2014

    Report

    Report Number
    3005462046-2014-00010
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AIR EMBOLISM OCCURRED DURING USE OF THE ANGIOSCULPT DEVICE. THE PT WAS GIVEN MEDICATION, THUS RESULTING IN ADDITIONAL INTERVENTION. THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE BALLOON HAD BEEN INFLATED AND THE RX PORT IS LACERATED. DURING FUNCTIONAL TESTING, THE BALLOON WAS INFLATED TO 2 ATM AND A PINHOLE LEAK WAS OBSERVED DISTAL TO THE PROXIMAL MARKER BAND. PER THE ANGIOSCULPT IFU, EMBOLISM IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE PT HAD IN-STENT RESTENOSIS. THE PHYSICIAN ATTEMPTED TO BALLOON THE LESION WITH AN ANGIOSCULPT BALLOON. THE BALLOON WAS INFLATED TWICE TO 8 ATM FOR 30 SECONDS. THE BALLOON WAS THEN REMOVED OUT OF THE BODY AND AN ANGIOGRAM WAS PERFORMED AND SHOWED THE LESION WAS STILL PRESENT. THE BALLOON WAS REINTRODUCED TO THE RCA AND WAS INFLATED TO 12 ATM. THE INDEFLATOR WAS UNABLE TO HOLD PRESSURE SO THE DEVICE WAS DEFLATED AND REMOVED FROM THE PT. AN ANGIOGRAM WITHOUT CONTRAST INJECTED AFTER SHOWED CONTRAST IN THE VESSEL AND AN AIR EMBOLISM. THE PT WENT BRADYCARDIC AND HER BLOOD PRESSURE DROPPED. THE EKG SHOWED ST ELEVATION. THE PT WAS GIVEN MEDICATIONS FORM THE NURSE AND WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205521 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) CATHETER, ANGIOPLASTY, CORONARY NWX ANGIOSCORE, INC. 2200-3015 F13090067

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R 0.014" GUIDE WIRE/6F INTRODUCER SHEATH/6F GUIDE| CATHETER