BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBEL

    MDR report key: 10083496 · Received May 22, 2020

    Report

    Report Number
    2134265-2020-06851
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 22, 2019
    Report Date
    July 15, 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 · 0

    DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF A REBEL BMS BALLOON CATHETER.THE SHAFT, HYPOTUBE, TIP AND BALLOON WERE MICROSCOPICALLY AND VISUALLY EXAMINED. THERE WERE NUMEROUS KINKS. THE BALLOON WAS TIGHTLY FOLDED. MICROSCOPIC INSPECTION REVEALED TIP DAMAGE. THE STENT WAS CRIMPED. THE STENT HAD MOVED DISTALLY ON THE BALLOON. THE STRUTS WERE BENT 6MM PROXIMALLY FROM THE DISTAL END OF THE STENT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. PREDILATION OF THE TARGET LESION WAS COMPLETED SUCCESSFULLY. AS THE 16 X 3.5 REBEL BARE METAL STENT WAS BEING IMPLANTED, STRUT DEFORMATION WAS NOTED AND THE DEVICE WAS PULLED BACK AND REMOVED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE AND WITH NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. PREDILATION OF THE TARGET LESION WAS COMPLETED SUCCESSFULLY. AS THE 16 X 3.5 REBEL BARE METAL STENT WAS BEING IMPLANTED, STRUT DEFORMATION WAS NOTED AND THE DEVICE WAS PULLED BACK AND REMOVED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE AND WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547755 REBEL STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION 10287 0022804561

    Patients

    Seq Age Sex Outcome Treatment
    1