BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 3031311 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02271
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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

    DEVICE EVALUATED BY MANUFACTURER: THE ROTABLATOR PLUS UNIT WAS RETURNED TO SITE WITHIN UNOPENED PACKAGING. ANALYSIS CONCLUDED THE DEVICE PACKAGING WAS COMPLETELY SEALED AND THE DEVICE HAD NOT BEEN USED. A VISUAL EXAMINATION OF THE COMPLAINT PLUS UNIT WAS NOT CARRIED OUT AS THE PACKAGING WAS SEALED AND THE RETURNED DEVICE WAS CONFIRMED TO BE UNUSED. 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 THE RETURNED DEVICE DID NOT SHOW ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02335. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. WHILE PREPARING THE 1.25MM ROTABLATOR ROTALINK BURR, THE DEVICE WAS BEING TESTED AT A ROTATIONAL SPEED OF APPROXIMATELY 180RPM WHEN THE ROTABLATOR ROTALINK BURR CAME INTO CONTACT WITH THE ROTAWIRE GUIDE WIRE AND FRACTURED THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 213425-2013-02335. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. WHILE PREPARING THE 1.25MM ROTABLATOR ROTALINK BURR, THE DEVICE WAS BEING TESTED AT A ROTATIONAL SPEED OF APPROXIMATELY 180RPM WHEN THE ROTABLATOR ROTALINK BURR CAME INTO CONTACT WITH THE ROTAWIRE GUIDE WIRE AND FRACTURED THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134112 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0015886201

    Patients

    Seq Age Sex Outcome Treatment
    1