BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    MDR report key: 17723271 · Received September 11, 2023

    Report

    Report Number
    2124215-2023-47959
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. ON AN UNSPECIFIED DATE, A NON-BOSTON SCIENTIFIC DRUG ELUTING STENT WAS PLACED IN THE MID RIGHT CORONARY ARTERY (RCA). IN AUGUST 2023, 50% IN-STENT RESTENOSIS (ISR) WAS NOTED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RCA. A 10MMX3.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED WHEN PRESSURIZED AT 4 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878803 WOLVERINE CORONARY CUTTING BALLOON MONORAIL CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION 3851 0030698641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STENT - 3.5 MM XIENCE