BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3010284 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01562
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED DAMAGE TO THE DISTAL END. THE COIL WAS UNRAVELED. THE CORE WIRE WAS FRACTURED AND THE BALL WELD WAS MISSING. A KINK WAS IDENTIFIED AT 158.5CM FROM THE PROXIMAL END. THE DIMENSIONS THAT COULD BE MEASURED MET 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 A STENTING TREATMENT PROCEDURE, THE GUIDE WIRE WAS STUCK IN A PREVIOUSLY IMPLANTED STENT. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE CROSSING A PREVIOUSLY IMPLANTED UNKNOWN STENT, DEPLOYED ONE MONTH PRIOR, THE AMPLATZ SUPER STIFF GUIDE WIRE BECAME STUCK IN THE STENT. THE PHYSICIAN HAD TO "PULL HARD" TO REMOVE THE WIRE AND IT BECAME STRETCHED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE GUIDE WIRE WAS STUCK IN A PREVIOUSLY IMPLANTED STENT. THE TARGET LESION DETAILS ARE UNKNOWN. WHILE CROSSING A PREVIOUSLY IMPLANTED UNKNOWN STENT, DEPLOYED ONE MONTH PRIOR, THE AMPLATZ SUPER STIFF GUIDE WIRE BECAME STUCK IN THE STENT. THE PHYSICIAN HAD TO "PULL HARD" TO REMOVE THE WIRE AND IT BECAME STRETCHED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114264 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465250

    Patients

    Seq Age Sex Outcome Treatment
    1