BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2001184 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00341
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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: ONE DEVICE WAS RECEIVED IN 2 PIECES, PROXIMAL AND DISTAL SIDE. VISUAL INSPECTION NOTED THAT THE WIRE WAS FRACTURED AT 131.3CM APPROX. FROM THE DISTAL END. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE FRACTURED SECTION WAS SENT TO SEM LAB FOR FRACTURE ANALYSIS. RESULTS: FRACTURE OCCURRED IN A TORSIONAL OVERLOAD DIRECTION DUE TO A REDUCTION IN THE CROSS-SECTIONAL AREA OF THE WIRE. NO MATERIAL ANOMALIES WERE FOUND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID #:2134265-2011-00469. IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, A WIRE BREAK OCCURRED. THE 90% STENOSED LESION TO BE TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. DURING THE SETTING OF THE PLATFORM SPEED OF THE ROTABLATOR ROTALINK PLUS 1.75MM BURR OUTSIDE OF THE BODY, THE EXTRA SUPPORT ROTAWIRE GUIDE WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS LISTED AS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID #:2134265-2011-00469. IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, A WIRE BREAK OCCURRED. THE 90% STENOSED LESION TO BE TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. DURING THE SETTING OF THE PLATFORM SPEED OF THE ROTABLATOR ROTALINK PLUS 1.75MM BURR OUTSIDE OF THE BODY, THE EXTRA SUPPORT ROTAWIRE GUIDE WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS LISTED AS GOOD.

    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 13709183

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTABLATOR ROTALINK PLUS 1.75MM