BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ GUIDE WIRE

    MDR report key: 2013446 · Received March 10, 2011

    Report

    Report Number
    2134265-2011-00510
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K040140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL AND MICROSCOPIC EVALUATION OF THE RETURNED GUIDE WIRE REVEALED SCRAPED PTFE ALONG THE WIRE. DEVICE MEASUREMENTS MET SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY ANOTHER DEVICE. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY INTERVENTIONAL PROCEDURE THE SURFACE OF THE GUIDE WIRE WAS NOTED TO BE ROUGH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY THAT CONTAINED A 90 DEGREE TAKE OFF. AN IQ 185CM, STRAIGHT TIP GUIDE WIRE HAD BEEN ADVANCED INTO THE CORONARY ARTERY WHEN THE PHYSICIAN DECIDED THAT ANOTHER CURVE NEEDED TO BE PUT INTO THE WIRE TO NAVIGATE THE TAKE OFF. AS THE WIRE WAS BEING REMOVED FROM THE NON-BSC TOUHY THE WIRE "GOT HUNG UP" AT THE TRANSITION AREA OF THE WIRE. THE O-RING OF THE TOUHY WAS OPENED MORE AND THE WIRE WAS REMOVED "EASILY". EXAMINATION OF THE WIRE REVEALED THE TRANSITION AREA FELT "ROUGH". THE PROCEDURE WAS COMPLETED WITH ANOTHER IQ 185CM, STRAIGHT TIP WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MISSING COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938950012

    Patients

    Seq Age Sex Outcome Treatment
    1 MERIT TOUHY