BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1936003 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05805
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL AND TACTILE EXAMINATION REVEALED THE DISTAL TIP WAS STRETCHED. KINKS WERE NOTED AT 7, 10 AND 12.5CM PROXIMAL FROM THE DISTAL TIP. THE PTFE COATING EXHIBITED EVIDENCE OF PEELING IN THE IMMEDIATE VICINITY OF THE NOTED KINKS. OUTER DIAMETER MEASUREMENTS TAKEN WERE WITHIN SPECIFICATIONS. NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED WITH THE DEVICE. 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 MFR#: 2134265-2010-04514. REPORTABLE BASED ON PRODUCT ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE PROSTHESIS (TAVI) TREATMENT PROCEDURE, A BALLOON CATHETER WOULD NOT ADVANCE OVER THE GUIDE WIRE. THE 035/260/3MM AMPLATZ SUPER STIFF GUIDE WIRE WAS ADVANCED THROUGH THE AORTIC VALVE TO THE LEFT VENTRICLE. RESISTANCE WAS NOTED WHILE ATTEMPTING TO ADVANCE A NON BSC PROSTHESIS DELIVERY CATHETER OVER THE GUIDE WIRE. AS THE PHYSICIAN WAS UNABLE TO ADVANCE THE CATHETER, THE GUIDE WIRE WAS EXCHANGED FOR ANOTHER 035/260/3MM AMPLATZ SUPER STIFF GUIDE WIRE. THE NON BSC PROSTHESIS DELIVERY CATHETER WAS ABLE TO BE ADVANCED TO THE INTENDED LOCATION AND THE PROSTHESIS WAS IMPLANTED. WHILE ATTEMPTING TO REMOVE THE CATHETER OVER THE SECOND WIRE, RESISTANCE WAS NOTED AND THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS OF THE FIRST AMPLATZ SUPER STIFF GUIDE WIRE REVEALED THE PTFE COATING WAS PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465020 12236308

    Patients

    Seq Age Sex Outcome Treatment
    1 COREVALVE CATHETER