BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3061483 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02349
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AFTER VISUAL INSPECTION BEFORE DECONTAMINATION PROCESS, DEVICE WAS RECEIVED SEPARATED IN TWO SEGMENTS. THE PROXIMAL PORTION MEASURED 191.8CM APPROXIMATELY AND THE DISTAL SECTION MEASURED 138.2CM APPROXIMATELY. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE (B)(4) LAB REVEALED EVIDENCE SUPPORT TORSION WITH BENDING AND A FINAL TENSION OVERLOAD EVENT IN AN AREA WITH WEAR REDUCTION AS MODE OF FAILURE FOR BOTH SAMPLES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DFU INSTRUCTS "ENSURE THAT THE FREE LUMEN ROTATIONAL SPEED OF THE BURR DOES NOT EXCEED 180,000 RPM FOR 1.25 MM TO 2.0 MM BURRS AND 160,000 RPM FOR THE 2.15 MM AND LARGER BURR SIZES." HOWEVER INFORMATION RECEIVED REPORTS THAT THE BURR WAS TESTED AT 200,000 RPM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-02350. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURED. AFTER LOADING THE 1.50MM ROTABLATOR ROTALINK PLUS BURR ONTO THE 330CM FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN ROTATED THE 1.50MM BURR AS A PRETEST OUTSIDE OF THE PATIENT BODY. IT WAS OBSERVED THAT THE GUIDE WIRE TWISTED OFF AND THE FRACTURED PIECE REMAINED IN THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-02350. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURED. AFTER LOADING THE 1.50MM ROTABLATOR ROTALINK PLUS BURR ONTO THE 330CM FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN ROTATED THE 1.50MM BURR AS A PRETEST OUTSIDE OF THE PATIENT BODY. IT WAS OBSERVED THAT THE GUIDE WIRE TWISTED OFF AND THE FRACTURED PIECE REMAINED IN THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-02350. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURED. AFTER LOADING THE 1.50MM ROTABLATOR ROTALINK PLUS BURR ONTO THE 330CM FLOPPY ROTAWIRE GUIDE WIRE, THE PHYSICIAN ROTATED THE 1.50MM BURR AS A PRETEST OUTSIDE OF THE PATIENT BODY. IT WAS OBSERVED THAT THE GUIDE WIRE TWISTED OFF AND THE FRACTURED PIECE REMAINED IN THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162758 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240020 15433663

    Patients

    Seq Age Sex Outcome Treatment
    1