BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 3030902 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02006
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT ONLY THE CATHETER WAS RETURNED WITH A GUIDEWIRE INSERTED IN THE DEVICE. THE BURR WAS DETACHED FROM THE CATHETER AND REMAINED ON THE GUIDEWIRE. MICROSCOPIC EXAMINATION OF THE BURR REVEALED THAT THE BURR WAS MOVING FREELY ON THE GUIDEWIRE. A SECTION OF RESIDUAL COIL WAS NOTABLE IN THE DISTAL BURR. NO ISSUE WAS NOTED WITH THE BURR. MICROSCOPIC EXAMINATION OF THE COIL REVEALED THAT THE DISTAL WAS STRETCHED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY INTERVENTION PROCEDURE, A DETACHMENT ISSUE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED A 1.25MM ROTALINK BURR TO THE LESION AND DURING ABLATION THE BURR GOT STUCK IN THE LESION. WHEN THE PHYSICIAN PULLED BACK TO RETRIEVE THE BURR, THE TIP OF THE BURR BROKE OFF THE CATHETER AND STAYED ON THE WIRE. THE ENTIRE SYSTEM WAS REMOVED AS ONE UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED SIZED QUANTUM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY INTERVENTION PROCEDURE, A DETACHMENT ISSUE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED A 1.25MM ROTALINK BURR TO THE LESION AND DURING ABLATION THE BURR GOT STUCK IN THE LESION. WHEN THE PHYSICIAN PULLED BACK TO RETRIEVE THE BURR, THE TIP OF THE BURR BROKE OFF THE CATHETER AND STAYED ON THE WIRE. THE ENTIRE SYSTEM WAS REMOVED AS ONE UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED SIZED QUANTUM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133625 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 14169840

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR