BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4800506 · Received May 27, 2015

    Report

    Report Number
    2134265-2015-03278
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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 MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COMPLAINT UNIT WAS RETURNED CONNECTED TO THE CATHETER. VISUAL EXAMINATION OF THE COMPLAINT NOTED NO ISSUES. THE ADVANCER KNOB WAS LOCKED UPON RETURN IN A BACKWARD POSITION, IT WAS LOOSENED AND ADVANCED IN ORDER TO INSPECT THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. A HANDSHAKE CONNECTION TEST ALSO OBSERVED NO ISSUES. THE DRIVE SHAFT, COIL AND SHEATH WERE INSPECTED AND THERE WAS NO DAMAGE NOTED. THE ANNULUS OF THE BURR WAS INSPECTED AND WAS OBSERVED TO BE DAMAGED. THERE WAS NO EVIDENCE OF A GUIDEWIRE RUNNING THROUGH THE DEVICE. 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2015-03279. IT WAS REPORTED THAT A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ PLUS WERE USED FOR TREATMENT. DURING PREPARATION, UPON SETTING OF THE ROTATIONAL SPEED OUTSIDE PATIENT'S BODY, THE ROTAWIRE WAS OBSERVED TO BE DETACHED AT THE SECTION WHERE IT MADE CONTACT WITH THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2015-03279. IT WAS REPORTED THAT A GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ PLUS WERE USED FOR TREATMENT. DURING PREPARATION, UPON SETTING OF THE ROTATIONAL SPEED OUTSIDE PATIENT'S BODY, THE ROTAWIRE WAS OBSERVED TO BE DETACHED AT THE SECTION WHERE IT MADE CONTACT WITH THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342487 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 17652497

    Patients

    Seq Age Sex Outcome Treatment
    1 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER