BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3193183 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04460
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY THE MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. THE VISUAL INSPECTION WAS PERFORMED, THE COATING PEELED ALONG THE BODY. DIMENSIONAL INSPECTION WAS PERFORMED AND ALL THE OUTER DIAMETER TAKEN WERE COMPARED AND ALL OF THEM ARE IN ACCORDING TO 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VASCULAR PROCEDURE, A GUIDEWIRE COATING ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. AS THE 035/260CM AMPLATZ SUPER STIFF GUIDEWIRE WAS ENTERING AN UNSPECIFIED CATHETER BUT STILL OUTSIDE OF THE PATIENT, THE BLUE COATING OF THE DISTAL PART OF THE GUIDE WIRE WAS "FLAKING OFF." THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLEED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VASCULAR PROCEDURE, A GUIDEWIRE COATING ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. AS THE 035/260 CM AMPLATZ SUPER STIFF GUIDEWIRE WAS ENTERING AN UNSPECIFIED CATHETER BUT STILL OUTSIDE OF THE PATIENT, THE BLUE COATING OF THE DISTAL PART OF THE GUIDE WIRE WAS "FLAKING OFF". THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292285 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465260 15405185

    Patients

    Seq Age Sex Outcome Treatment
    1