BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBEL

    MDR report key: 10005183 · Received April 28, 2020

    Report

    Report Number
    2134265-2020-05458
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    March 6, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER: THE REBEL BARE METAL STENT WAS RETURNED AND ANALYSIS WAS COMPLETED. RETURNED PRODUCT CONSISTED OF A REBEL BMS STENTED CATHETER. THE BALLOON WAS LOOSELY FOLDED. THE STENT WAS SECURED BETWEEN THE MARKERBANDS. THE HYPOTUBE, OUTER SHAFT, INNER SHAFT, BALLOON, STENT AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS ALONG THE CATHETER. THE PROXIMAL AND DISTAL ENDS OF THE STENT IS DAMAGED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED 8 APRIL 2020. IT WAS REPORTED THAT THE 20 X 4.00 REBEL BARE METAL STENT WAS UNABLE TO PASS THROUGH THE 85% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD.) THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470171 REBEL STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION 10288 0024006193

    Patients

    Seq Age Sex Outcome Treatment
    1