BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2103470 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-01902
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP WAS ELONGATED AND BENT. THE WIRE ALSO PRESENTS SCRAPED COATING IN SEVERAL SECTIONS ALONG THE WIRE. THE OUTER DIAMETER OF THE WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATION. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE, TRACKING DIFFICULTIES WITH A GUIDE WIRE OCCURRED. THE TARGET ANATOMY WAS LOCATED IN THE LIVER. THIS .035" AMPLATZ SS GUIDE WIRE WAS ADVANCED PERCUTANEOUSLY INTO THE BILIARY TREE AND THEN A BALLOON CATHETER WAS INSERTED OVER THE WIRE TO PRE-DILATE THE BILE DUCT. THE BALLOON CATHETER WOULD NOT ADVANCE OVER THE TIP OF THE GUIDE WIRE. THE BALLOON CATHETER WAS REMOVED AND ANOTHER MANUFACTURERS' CATHETER WAS ADVANCED OVER THE WIRE. THE AMPLATZ WIRE WAS THEN REMOVED FROM THE PATIENT AND A NEW AMPLATZ WIRE WAS INSERTED AND ADVANCED THROUGH THE NON-BSC CATHETER. THE CATHETER WAS EXCHANGED FOR THE PREVIOUSLY USED BALLOON CATHETER AND WAS ABLE TO EASILY TRACK OVER THE AMPLATZ WIRE. ONCE OUTSIDE THE PATIENT, THE AMPLATZ WIRE WAS NOTED TO HAVE A SMALL IRREGULARITY ON THE DISTAL TIP. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SCRAPED COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465260 13814252

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK BILIARY MANIPULATION CATHETER