BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOREFLEX NC PTCA CATHETER NON-COMPLIANT BALLOON

    MDR report key: 15276334 · Received August 22, 2022

    Report

    Report Number
    MW5111654
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 19, 2022
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BALLOON BURST DURING INFLATION LEADING TO A CORONARY DISSECTION. CARDIOVASCULAR SYSTEMS, INC. (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202811 SCOREFLEX NC PTCA CATHETER NON-COMPLIANT BALLOON CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 3.0MM X 15MM 3614212206

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention