BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2151813 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02679
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ROTALINK BURR WAS RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE DEVICE REVEALED A KINK IN THE COIL OF THE CATHETER NEAR THE HANDSHAKE CONNECTION. THE RETURNED DEVICE WAS ATTACHED TO A CONTROL ADVANCER UNIT AND A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE HANDSHAKE CONNECTION. A CONNECT/DISCONNECT TEST WAS ALSO CONDUCTED. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. THE BURR WAS MICROSCOPICALLY EXAMINED AND FOUND TO BE FLARED AND MISSHAPEN. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. A SCRATCH TEST A WAS PERFORMED TO EXAMINE THE CUTTING ACTION OF THE RETURNED BURR. THE DIAMOND PLATED AREA OF THE BURR WAS SCRATCHED ALONG THE SIDE OF A SINGLE EDGE BLADE. WHEN THE SIDE OF THE BLADE WAS VISUALLY EXAMINED, A SCRATCH MARK FROM WHERE THE BURR CAME INTO CONTACT WITH THE SIDE OF THE BLADE WAS NOTED DEMONSTRATING THAT THERE WERE NO ISSUES WITH THE CUTTING ACTION OF THE BLADES. THE DAMAGE TO THE BURR WAS CONSISTENT WITH THE BURR COMING INTO CONTACT WITH THE WIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE LABELING REVIEW INDICATED THAT THE ROTABLATOR DEVICE WAS NOT USED IN ACCORDANCE WITH THE LABELING. ROTABLATOR DFU STATES THE FOLLOWING: "GRIP THE DRIVE SHAFT CONNECTIONS GENTLY. NEVER GRIP OR PULL ON THE FLEXIBLE SHAFT AND AVOID GRIPPING THE BROWN SLIDE TUBE DURING THIS STEP". "NEVER ADVANCE THE ROTATING BURR TO THE POINT OF CONTACT WITH THE GUIDE WIRE SPRING TIP. SUCH CONTACT COULD RESULT IN DISTAL DETACHMENT AND EMBOLIZATION OF THE TIP". "VERIFY THAT THE GUIDE WIRE TIP IS DISTAL TO THE LESION AND WILL NOT COME IN CONTACT WITH THE ROTATING BURR". "ALWAYS KEEP THE BURR ADVANCING OR RETRACTING WHILE IT IS ROTATING. MAINTAINING THE BURR IN ONE LOCATION WHILE IT IS ROTATING MAY LEAD TO EXCESSIVE TISSUE REMOVAL OR DAMAGE TO THE ROTABLATOR SYSTEM". THEREFORE THE ROOT CAUSE CLASSIFICATION IS USER RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2011-02680. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. ROTATIONAL ATHERECTOMY WAS PERFORMED AFTER MULTIPLE UNSPECIFIED BALLOONS WERE UNABLE TO CROSS THE LESION. A 1.25MM ROTALINK BURR WAS USED TO SUCCESSFULLY TO PERFORM ABLATION WITH NO DIFFICULTIES. TO CONTINUE THE PROCEDURE, THE PHYSICIAN THEN SWITCHED TO A 2.00MM ROTALINK BURR HOWEVER THE BURR WAS NOT PROPERLY CONNECTED TO THE ROTALINK ADVANCER. WHEN THE CONNECTION WAS PULLED ON, THE CABLE BECAME UNWOUND AND "SPIRALED UP." ALSO DURING THE PROCEDURE, THE ROTALINK BURR CAME IN CONTACT WITH THE DISTAL SPRING COIL TIP OF THE FLOPPY ROTAWIRE GUIDE WIRE AND THE GUIDE WIRE BROKE. THE DISTAL SECTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2011-02680. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. ROTATIONAL ATHERECTOMY WAS PERFORMED AFTER MULTIPLE UNSPECIFIED BALLOONS WERE UNABLE TO CROSS THE LESION. A 1.25MM ROTALINK BURR WAS USED TO SUCCESSFULLY TO PERFORM ABLATION WITH NO DIFFICULTIES. TO CONTINUE THE PROCEDURE, THE PHYSICIAN THEN SWITCHED TO A 2.00MM ROTALINK BURR HOWEVER THE BURR WAS NOT PROPERLY CONNECTED TO THE ROTALINK ADVANCER. WHEN THE CONNECTION WAS PULLED ON, THE CABLE BECAME UNWOUND AND "SPIRALED UP." ALSO DURING THE PROCEDURE, THE ROTALINK BURR CAME IN CONTACT WITH THE DISTAL SPRING COIL TIP OF THE FLOPPY ROTAWIRE GUIDE WIRE AND THE GUIDE WIRE BROKE. THE DISTAL SECTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680050 13015928

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: 330CM ROTAWIRE| ROTABLATOR ADVANCER