BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER

    MDR report key: 16253799 · Received January 26, 2023

    Report

    Report Number
    MW5114523
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 16, 2023
    Report Date
    January 24, 2023
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CORONARY INTERVENTION, AN ANGIOSCULPT PTCA SCORING BALLOON WAS INSERTED BY THE CARDIOLOGIST, THROUGH THE SHEATH INTO THE PT'S BODY. UPON INSERTION THE BACK END OF THE DEVICE (PIECE WITH THE HUB) BROKE OFF. THE PIECE THAT WAS IN THE SHEATH WAS EASILY REMOVED. NO PIECE OF THE DEVICE REMAINED IN THE PT. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5394 ANGIOSCULPT PTCA SCORING BALLOON CATHETER CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX SPECTRANETICS CORP. 2200-3510 G21040088

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other