BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK BURR

    MDR report key: 11206884 · Received January 21, 2021

    Report

    Report Number
    2134265-2021-00378
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    November 16, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729185864
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHEATH, COIL, BURR AND ANNULUS WERE MICROSCOPICALLY AND VISUALLY EXAMINED. VISUAL AND MICROSCOPIC EXAMINATION REVEALED NO DAMAGES. DEVICE TO DEVICE INTERACTION TEST WAS PERFORMED BY INSERTING A TEST GUIDEWIRE INTO THE BURR CATHETER AND IT WAS UNABLE TO PASS THROUGH. THE COIL WAS CUT OPEN AND A FIBROUS MATERIAL WAS FOUND INSIDE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS FOUND DAMAGE AN UNKNOWN FOREIGN MATTER INSIDE THE COIL.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07JAN2021. IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT CROSS THE CONNECTION PART BETWEEN THE ADVANCER AND BURR. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTALINK BURR WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COULD NOT CROSS THE CONNECTION PART BETWEEN THE ADVANCER AND BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A FIBROUS MATERIAL WAS FOUND INSIDE THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107088 ROTALINK BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3320 0023324075 08714729185864

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR