BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4060163 · Received September 4, 2014

    Report

    Report Number
    2134265-2014-05403
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE INSPECTION WAS PERFORMED AND FOUND THAT THE DEVICE WAS FRACTURED IN TWO SECTIONS. MOREOVER, THE DEVICE PRESENTS SEVERAL KINKS ON BOTH SECTIONS. ALL THE OUTER DIAMETER MEASUREMENTS ARE 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05405. IT WAS REPORTED THAT A ROTAWIRE FRACTURE OCCURRED. A 1.50MM ROTALINK¿ PLUS AND A 330CM ROTAWIRE¿ WERE SELECTED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT CORONARY ARTERY. DURING PREPARATION, STRONG RESISTANCE WAS ENCOUNTERED UPON LOADING THE FIRST 1.50MM ROTALINK¿ PLUS ONTO THE ROTAWIRE. THE DEVICE WAS EXCHANGED FOR ANOTHER 1.50MM ROTALINK¿ PLUS. DURING PLATFORMING OUTSIDE OF THE PATIENT, THE WIRE SNAPPED AFTER APPROXIMATELY 20 SECONDS. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW ROTAWIRE AND BURR WITHOUT ISSUE. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05405. IT WAS REPORTED THAT A ROTAWIRE FRACTURE OCCURRED. A 1.50MM ROTALINK¿ PLUS AND A 330CM ROTAWIRE¿ WERE SELECTED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT CORONARY ARTERY. DURING PREPARATION, STRONG RESISTANCE WAS ENCOUNTERED UPON LOADING THE FIRST 1.50MM ROTALINK¿ PLUS ONTO THE ROTAWIRE. THE DEVICE WAS EXCHANGED FOR ANOTHER 1.50MM ROTALINK¿ PLUS. DURING PLATFORMING OUTSIDE OF THE PATIENT, THE WIRE SNAPPED AFTER APPROXIMATELY 20 SECONDS. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW ROTAWIRE AND BURR WITHOUT ISSUE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540202 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240020 16984442

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR