BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 15896136 · Received December 1, 2022

    Report

    Report Number
    2124215-2022-50138
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    July 9, 2022
    Report Date
    December 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATSUKAWA, R., MATSUURA, H., TOKUTOME, M., OKAHARA, A., HARA, A., OKABE, K., KAWAI, S., & MUKAI, Y. (2022). USE OF A CUTTING BALLOON REDUCES THE INCIDENCE OF DISTAL EMBOLISM IN ACUTE CORONARY SYNDROME REQUIRING PREDILATATION BEFORE STENTING. CIRCULATION REPORTS, 4(8), 345-352. HTTPS://DOI.ORG/10.1253/CIRCREP.CR-22-0056.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DISTAL EMBOLISM OCCURRED. THIS STUDY RETROSPECTIVELY ANALYZED DATA FOR 175 ACUTE CORONARY SYNDROME PATIENTS WITH SOLID LESIONS THAT REQUIRED PREDILATATION. THE PATIENTS WERE DIVIDED INTO 2 GROUPS FOR ANALYSIS, A CUTTING BALLOON GROUP AND A CONVENTIONAL BALLOON GROUP. THE CUTTING BALLOON GROUP CONTAINED 39 PATIENTS (36 TREATED WITH THE WOLVERINE CUTTING BALLOON AND 3 TREATED WITH THE FLEXTOME CUTTING BALLOON). THE CONVENTIONAL BALLOON GROUP CONTAINED 136 PATIENTS (104 TREATED WITH SEMICOMPLIANT BALLOONS AND 32 TREATED WITH NON-COMPLIANT BALLOONS). DISTAL EMBOLISMS OCCURRED IN 48 PATIENTS. THE OCCURRENCE OF DISTAL EMBOLISM WAS SIGNIFICANTLY LOWER IN THE CUTTING BALLOON THAN CONVENTIONAL BALLOON GROUP. MULTIVARIATE ANALYSIS SHOWED THAT THE OCCURRENCE OF DISTAL EMBOLISM WAS POSITIVELY ASSOCIATED WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION GRADE AND THE PRESENCE OF ATTENUATED PLAQUE, BUT NEGATIVELY ASSOCIATED WITH THE USE OF A CUTTING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853302 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS NWX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other