BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2133180 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02347
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND IT TO APPEAR VISUALLY CORRECT WITH NO INDICATION OF ANY DEFECT OR ANOMALY. ALL THE OUTER DIAMETER MEASUREMENTS WERE WITHIN THE SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED AS EXAMINATION OF THE RETURNED PRODUCT REVEALED NO DAMAGE OR IRREGULARITIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUROUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN FOUND A KINK IN THE 330CM ROTA GUIDE WIRE WHILE LOADING THE ROTA BURR. THE PHYSICIAN THEREFORE REMOVED THE GUIDE WIRE FROM THE ROTALINK PLUS UNIT. THE DEVICE THEN BROKE AT THE LOCATION OF THE KINK. THE BREAK OCCURRED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUROUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE PHYSICIAN FOUND A KINK IN THE 330CM ROTA GUIDE WIRE WHILE LOADING THE ROTA BURR. THE PHYSICIAN THEREFORE REMOVED THE GUIDE WIRE FROM THE ROTALINK PLUS UNIT. THE DEVICE THEN BROKE AT THE LOCATION OF THE KINK. THE BREAK OCCURRED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 - COSTA RICA H802228240020

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTALINK PLUS| ROTALINK BURR