BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2248546 · Received September 14, 2011

    Report

    Report Number
    2134265-2011-04054
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A TUG TEST AND A CONNECT/DISCONNECT TEST WERE PERFORMED TO EXAMINE THE INTEGRITY OF THE HANDSHAKE CONNECTION AS PER PROCEDURE. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT WAS MADE TO WIRE THE PLUS UNIT USING A CONTROL GUIDEWIRE. RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. THERE WAS EVIDENCE OF CORROSION IN THE CATHETER SHEATH. THE BURR WAS MICROSCOPICALLY EXAMINED AND IT WAS FOUND THAT THE BURR ANNULUS WAS MISSHAPENED. A SCRATCH TEST WAS PERFORMED AND THE BURR'S CUTTING ACTION WAS ACCEPTABLE. THE DAMAGE TO THE BURR IS CONSISTENT WITH THE BURR COMING INTO CONTACT WITH THE WIRE. 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 PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. SAME CASE AS MDR ID 2134265-011-0272. IT WAS REPORTED THAT DURING PREP FOR A ROTATIONAL ATHERECTOMY PROCEDURE, A ROTAWIRE GUIDE WIRE FRACTURE OCCURRED. WHILE CONDUCTING THE PLATFORM TESTING OF A 1.75MM ROTALINK PLUS DEVICE THE 330CM FLOPPY ROTAWIRE FRACTURED. THE ROTAWIRE GUIDE WIRE WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE VESSEL WAS UNABLE TO BE REWIRED WITH A NEW GUIDE WIRE. THE PROCEDURE WAS UNABLE TO BE COMPLETED AT THIS TIME AND WAS RE-SCHEDULED FOR A LATER DATE. THE SITE STATED THAT THERE WERE NO PROBLEMS WITH THE ROTALINK PLUS DEVICE. THE ROTABLATOR DEVICE NEVER ENTERED THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED THAT THERE WAS ANNULUS DAMAGE TO THE BURR CONSISTENT WITH THE ROTATING BURR COMING IN CONTACT WITH THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 14187558

    Patients

    Seq Age Sex Outcome Treatment
    1 330M FLOPPY ROTAWIRE GUIDE WIRE.