BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBEL

    MDR report key: 12910310 · Received December 1, 2021

    Report

    Report Number
    2134265-2021-15070
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    September 6, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A REBEL BMS BALLOON CATHETER. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THE RAPID PORT EXCHANGE WAS DAMAGED. THE STENT WAS FOUND MISPLACED WITHIN 1MM DISTAL FROM THE PROXIMAL MARKERBAND. THE STENT BRACKET MOST PROXIMAL FROM THE TIP OF THE DEVICE WAS PULLED UP AWAY FROM THE BALLOON. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT ATTACHED, AND THE TIP OF THE DEVICE WAS DAMAGED. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT, AS THERE WAS RAPID PORT EXCHANGE AND TIP DAMAGE LIKELY CONTRIBUTING TO THE REPORTED CROSSING DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED. THE STENT TO THE DEVICE WAS ALSO DAMAGED. THIS REFLECTS THE DEVICE GETTING DAMAGED UPON REMOVAL AND CAN ALSO CONTRIBUTE TO THE REPORTED CROSSING DIFFICULTY.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23 NOVEMBER 2021. IT WAS REPORTED THAT FAILURE TO CROSS A LESION OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 24 X 3.00 REBEL STENT WAS ADVANCED, BUT COULD NOT PASS THROUGH THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. HOWEVER, DEVICE RETURNED AND ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808448 REBEL STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION 10289 0025939740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown