BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 15896590 · Received December 1, 2022

    Report

    Report Number
    2124215-2022-50261
    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 UTILIZED PSEUDO-THROMBUS IN AN EX VIVO EXPERIMENTAL MODEL TO COMPARE THROMBUS DISPERSAL USING A CUTTING BALLOON AND NON-COMPLIANT BALLOON. THERE WERE NO PATIENTS INVOLVED IN THIS MODEL. THE PSEUDO-THROMBUS LESIONS WERE DILATED WITH EITHER A CUTTING BALLOON (WOLVERINE 3.0X10MM, 6ATM) OR A NON-COMPLIANT BALLOON (EMERGE 3.0X12MM, AT 12ATM) FOR 10 SECONDS EACH. THE WEIGHT OF THE PSEUDO-THROMBUS MODEL WAS MEASURED BEFORE AND AFTER DILATATION. THE DIFFERENCE IN WEIGHT FROM BEFORE TO AFTER BALLOON DILATATION WAS DIVIDED BY THE ORIGINAL WEIGHT TO OBTAIN THE PSEUDO-THROMBUS DISPERSAL RATE. PSEUDO-THROMBUS DISPERSAL, REGARDED AS AN INDEX OF DISTAL EMBOLI, WAS LOWER IN THE CUTTING BALLOON THAN THE NON-COMPLIANT BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960874 WOLVERINE CORONARY CUTTING BALLOON CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other