BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3011293 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01445
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE DISTAL TIP WAS ELONGATED AND BENT AT 251CM, 252.3, 253CM, 256CM AND 258CM FROM THE PROXIMAL END. ALSO, THE BODY HAS A JUMP COIL AT 213.3CM FROM THE PROXIMAL END, AND THE BODY IS PEELED. 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2013. IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE, GUIDEWIRE KINK OCCURRED. THE STENOSIS WAS CROSSED USING A TAPERED 5F CATHETER AND AN AMPLATZ SUPER STIFF GUIDEWIRE .035/260 WAS PASSED THROUGH THE CATHETER BEYOND THE STENOSIS. THE CATHETER WAS THEN WITHDRAWN, AND AN UNSPECIFIED BALLOON CATHETER WAS LOADED ON THE WIRE. THE CATHETER TIP SNAGGED ABRUPTLY AT ROUGHLY MID AORTIC AND WAS UNABLE TO ADVANCE ANY FURTHER, THE CATHETER WAS THEN REMOVED, CLEANED AND RE-ADVANCED OVER THE WIRE, BUT IT SNAGGED AT THE SAME POINT. THE CATHETER AND THE WIRE WERE REMOVED TOGETHER. THE GUIDEWIRE PRESENTED A KINK IN ITS LENGTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ WIRE AND THE SAME BALLOON CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. HOWEVER, PRODUCT ANALYSIS REVEALED THAT THE COATING WAS PARTIALLY PEELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113914 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465260

    Patients

    Seq Age Sex Outcome Treatment
    1