BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1994398 · Received February 17, 2011

    Report

    Report Number
    2134265-2011-00450
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 18, 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.: THE COMPLAINT DEVICE WAS RECEIVED IN TWO PIECES WITHOUT ITS ORIGINAL POUCH, OUTSIDE THE HOOP. VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A FRACTURE APPROXIMATELY 328CM FROM THE PROXIMAL END. SEM FRACTURE ANALYSIS REVEALED THAT THE FRACTURE SITE EXHIBITED EVIDENCE OF COMPRESSION AND TENSION. THE FRACTURE SURFACE EXHIBITED A FIBROUS APPEARING MATERIAL THAT IS THE LONGITUDINAL BOUNDARIES OF THE WIRE. FRACTURE OF THE CORE WIRE OCCURRED DUE TO A BENDING OVERLOAD. EXAMINATION REVEALED KINKS ALONG THE GUIDE WIRE AT 8CM, 59.8CM, 109CM, AND 190.5CM, FROM THE DISTAL END. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 MFT. #: 2134265-2011-00451 REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6)-2011. IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN NOTED AN ISSUE WHILE LOADING THE 1.75 ROTALINK BURR ON THE ROTAWIRE GUIDE WIRE. DURING PLATFORMING OF THE 1.75MM ROTALINK BURR, THE ROTAWIRE KINKED AND THE SPRING TIP BECAME DETACHED. THE SYSTEM STALLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.75MM ROTALINK BURR AND ROTAWIRE GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFT. #: 2134265-2011-00451. REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011. IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX (CX) ARTERY. THE PHYSICIAN NOTED AN ISSUE WHILE LOADING THE 1.75 ROTALINK BURR ON THE ROTAWIRE GUIDE WIRE. DURING PLATFORMING OF THE 1.75MM ROTALINK BURR, THE ROTAWIRE KINKED AND THE SPRING TIP BECAME DETACHED. THE SYSTEM STALLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.75MM ROTALINK BURR AND ROTAWIRE GUIDE WIRE. NO PATIENT 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 H802228240021

    Patients

    Seq Age Sex Outcome Treatment
    1