BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2103149 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-02126
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ROTABLATOR CATHETER UNIT WAS CONNECTED TO THE ADVANCER ON THE RETURN OF THIS DEVICE FOR INVESTIGATION. THE RELATED GUIDE WIRE WAS RETURNED WITH THE ROTALINK UNIT. THE GUIDE WIRE WAS NOT INSERTED IN THE CATHETER OR ADVANCER UNIT. IT WAS NOTED THAT THE BURR OF THE CATHETER UNIT WAS DETACHED FROM THE CATHETER AND WAS NOT RETURNED WITH THE DEVICE FOR ANALYSIS. THE DISTAL SECTION OF THE COIL WAS BROKEN AND STRETCHED. THE BURR COULD NOT BE MICROSCOPICALLY EXAMINED AS IT WAS NOT RETURNED WITH THE CATHETER. 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 PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2011-02275. 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: 2134265-2011-02275. 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 - CORK H802227680030 0013655427

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention GUIDE CATHETER: 7 FR AR1| BALLOON: RYUJIN 1.25X15MM