BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2062791 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01471
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ROTABLATOR PLUS UNIT WAS RETURNED TO SITE CONNECTED TOGETHER. ON VISUAL EXAMINATION IT WAS NOTED THAT BURR WAS ATTACHED TO THE COIL BUT THE PROXIMAL COIL WAS BROKEN. THE PLUS UNIT WAS UNSNAPPED AND IT WAS NOTED THAT THE COIL NEAR THE HANDSHAKE CONNECTION WAS BROKEN AND STRETCHED. THERE WAS A KINK IN THE CATHETER SHEATH APPROXIMATELY 87CM FROM THE STRAIN RELIEF. THE BURR WAS MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THE ANNULUS. NO ISSUES WERE NOTED WITH THE DIAMONDS ON THE BURR. THE PROXIMAL AND DISTAL COIL WAS MICROSCOPICALLY EXAMINED. IT WAS NOTED THAT THE PROXIMAL COIL WAS BROKEN AND STRETCHED. THE HANDSHAKE CONNECTION OF THE ADVANCER AND CATHETER UNIT WERE TESTED AND NO ISSUES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SHEATH DAMAGE OCCURRED. NO LESION OR ANATOMY INFORMATION IS AVAILABLE. THE PHYSICIAN WAS ADVANCING THE 1.5MM ROTABLATOR ROTALINK PLUS BURR ON THE GUIDE WIRE, AND NOTED THAT THE BURR CONTINUED TO ADVANCED HOWEVER THE SHEATH DETACHED AND DID NOT MOVE. THE PHYSICIAN REMOVED THE MATERIAL WITHOUT DIFFICULTY AND COMPLETED THE PROCEDURE WITH ANOTHER ROTABLATOR ROTALINK PLUS UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 13775089

    Patients

    Seq Age Sex Outcome Treatment
    1