BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACK-UP MEIER

    MDR report key: 3771124 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02142
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K020283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE VISUAL INSPECTION WAS PERFORMED AND THE COATING PEELED ALONG THE BODY. ALL THE OUTER DIAMETER MEASUREMENTS MET SPECIFICATIONS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS MFR ID # 2134265-2014-02141. IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE A GUIDE WIRE COATING ISSUE OCCURRED. DURING PLACEMENT OF A NON-BSC STENT GRAFT IN THE AORTA, THE PHYSICIAN NOTED THAT THE COATING OF THE BACK UP MEIER GUIDEWIRE WAS PEELING OFF A SECTION OF THE WIRE THAT WAS LOCATED OUTSIDE THE PATIENT. THE PHYSICIAN DID NOT EXCHANGE THE GUIDEWIRE SO NOT TO RISK LOSING THE ACCESS TO THE LESION. WHEN THE WIRE WAS REMOVED FROM THE PATIENT IT WAS CONFIRMED THAT COATING WAS PARTIALLY PEELED. THE ISSUE OCCURRED WITH A SECOND BACK UP MEIER GUIDEWIRE ALSO. THE PROCEDURE WAS COMPLETED WITH THE USE OF THESE TWO WIRES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2014-02141. IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE A GUIDE WIRE COATING ISSUE OCCURRED. DURING PLACEMENT OF A NON-BSC STENT GRAFT IN THE AORTA, THE PHYSICIAN NOTED THAT THE COATING OF THE BACK UP MEIER GUIDEWIRE WAS PEELING OFF A SECTION OF THE WIRE THAT WAS LOCATED OUTSIDE THE PATIENT. THE PHYSICIAN DID NOT EXCHANGE THE GUIDEWIRE SO NOT TO RISK LOSING THE ACCESS TO THE LESION. WHEN THE WIRE WAS REMOVED FROM THE PATIENT IT WAS CONFIRMED THAT COATING WAS PARTIALLY PEELED. THE ISSUE OCCURRED WITH A SECOND BACK UP MEIER GUIDEWIRE ALSO. THE PROCEDURE WAS COMPLETED WITH THE USE OF THESE TWO WIRES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250120 BACK-UP MEIER WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H965SCH306011

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK ZENITH STENTGRAFT