BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2103148 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-02275
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATED BY MFR: THE VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE GUIDE WIRE WAS RETURNED WITH THE ROTABURR ATTACHED ON IT. AFTER PERFORMING THE PRODUCT ANALYSIS, THE ROTABURR COULD REMOVE EASILY FROM THE ROTAWIRE. MOREOVER, THE DEVICE APPEARS VISUALLY CORRECT AND DOES NOT PRESENT INDICATION OF ANY DEFECT OR ANOMALY. THE OUTER DIAMETER WAS VERIFIED AND THE UNIT WAS WITHIN SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02126. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A BURR DETACHMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 1.5MM ROTALINK BURR WAS PLATFORMED OUTSIDE OF THE BODY WITH NO ISSUES AND TRACKED WITH MINIMAL RESISTANCE TO THE DISTAL TIP OF THE GUIDE CATHETER. DURING THE FIRST AND ONLY RUN, BURRING COMMENCED FOR 8 SECONDS AND THEN STOPPED. THE PHYSICIAN TRIED TO REPOSITION THE GUIDE CATHETER AND BURR BY PULLING IT BACK TOWARDS THE OSTIUM OF THE RCA FOR IT HAD DEEP SEATED. WHEN PULLING THE TWO BACK, THE BURR SHEATH WITHDREW WITH NO RESISTANCE APPROXIMATELY 30 MM, BUT THE BURR TIP STAYED. IT WAS THEN NOTICED THAT THE BURR HAD DETACHED FROM ITS SHAFT. A SNARE WAS USED TO REMOVE THE ROTAWIRE AND BURR TOGETHER. ANGIOGRAPHY WAS USED TO ENSURE THAT THERE WAS NO VESSEL DAMAGE. THE CASE WAS CANCELLED SINCE ANOTHER SUITABLE GUIDE CATHETER WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02126. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A BURR DETACHMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE 1.5MM ROTALINK BURR WAS PLATFORMED OUTSIDE OF THE BODY WITH NO ISSUES AND TRACKED WITH MINIMAL RESISTANCE TO THE DISTAL TIP OF THE GUIDE CATHETER. DURING THE FIRST AND ONLY RUN, BURRING COMMENCED FOR 8 SECONDS AND THEN STOPPED. THE PHYSICIAN TRIED TO REPOSITION THE GUIDE CATHETER AND BURR BY PULLING IT BACK TOWARDS THE OSTIUM OF THE RCA FOR IT HAD DEEP SEATED. WHEN PULLING THE TWO BACK, THE BURR SHEATH WITHDREW WITH NO RESISTANCE APPROXIMATELY 30 MM, BUT THE BURR TIP STAYED. IT WAS THEN NOTICED THAT THE BURR HAD DETACHED FROM ITS SHAFT. A SNARE WAS USED TO REMOVE THE ROTAWIRE AND BURR TOGETHER. ANGIOGRAPHY WAS USED TO ENSURE THAT THERE WAS NO VESSEL DAMAGE. THE CASE WAS CANCELLED SINCE ANOTHER SUITABLE GUIDE CATHETER WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE 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 - COSTA RICA H802232390010 13691972

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention