BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1862259 · Received October 8, 2010

    Report

    Report Number
    2134265-2010-04493
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CATHETER BODY WAS DISMANTLED AND RETURNED WITH THE PLUS UNIT. AN INITIAL EXAMINATION OF THE COMPLAINT PLUS UNIT WAS PERFORMED. THE CATHETER BODY WAS PLACED BACK ON THE CATHETER DEVICE AND TUG AND CONNECT/DISCONNECT TESTS WERE PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT TO WIRE GUIDE THE UNIT USING A CONTROL GUIDEWIRE MET RESISTANCE IN THE ANNULUS OF THE BURR. MICROSCOPIC EXAMINATION OF THE BURR REVEALED THAT THE BURR ANNULUS WAS SEVERELY MISSHAPEN. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. A WHITE POWDER/DRIED SALINE SUBSTANCE WAS NOTED ON THE DISTAL COIL. THE COIL WAS SOAKED IN WARM WATER AND THE WHITE POWDER/DRIED SALINE WAS DISSOLVED FROM THE COIL. IT IS PROBABLE THAT THE WHITE POWDER WAS DRIED SALINE FROM DURING THE PROCEDURE. THE BURR WAS MICROSCOPICALLY EXAMINED AGAIN AND NO BURNING MATERIAL WAS OBSERVED ON THE TIP OF THE BURR OR ANY WHERE ON THE COIL. A SCRATCH TEST WAS PERFORMED ON THE BURR AND CONFIRMED THAT THE BURR'S CUTTING ACTION WAS ACCEPTABLE. THE DAMAGE TO THE BURR IS 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 ROOT CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE USER RELATED AS PER THE DFU THE FOLLOWING INSTRUCTIONS WERE NOT FOLLOWED: "NEVER ADVANCE THE ROTATING BURR TO THE POINT OF CONTACT WITH THE GUIDEWIRE SPRING TIP. SUCH CONTACT COULD RESULT IN DISTAL DETACHMENT AND EMBOLIZATION OF THE TIP." (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2010-04494. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, FOREIGN MATERIAL WAS NOTED. DURING TESTING OF THE ROTATIONAL SPEED OF A 1.50MM ROTABLATOR ROTALINK BURR AND A 325CM ROTAWIRE GUIDE WIRE, THE GUIDE WIRE FRACTURED. IT WAS NOTED THAT THERE WAS A GOOD FLOW OF SALINE. AFTER THE FRACTURE OCCURRED THE PHYSICIAN OBSERVED A MATERIAL ATTACHED ON THE TIP OF THE BURR WHICH APPEARED TO BE "A BURNING MATERIAL". THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.50MM ROTABLATOR BURR AND ANOTHER 325CM ROTAWIRE GUIDE WIRE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2010-04494. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, FOREIGN MATERIAL WAS NOTED. DURING TESTING OF THE ROTATIONAL SPEED OF A 1.50MM ROTABLATOR ROTALINK BURR AND A 325CM ROTAWIRE GUIDE WIRE, THE GUIDE WIRE FRACTURED. IT WAS NOTED THAT THERE WAS A GOOD FLOW OF SALINE. AFTER THE FRACTURE OCCURRED THE PHYSICIAN OBSERVED A MATERIAL ATTACHED ON THE TIP OF THE BURR WHICH APPEARED TO BE "A BURNING MATERIAL". THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.50MM ROTABLATOR BURR AND ANOTHER 325CM ROTAWIRE GUIDE WIRE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 13181226

    Patients

    Seq Age Sex Outcome Treatment
    1 325CM ROTAWIRE GUIDE WIRE