BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE GUIDEWIRE

    MDR report key: 1994090 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00552
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP WAS COATED WITH POLY WITH NO EVIDENCE OF MISSING COATING. KINKS WERE LOCATED 1.5CM, 2CM, 3CM AND 4CM FROM THE DISTAL END OF THE WIRE. AN AREA OF PEELED COATING WAS LOCATED 19.8CM FROM THE PROXIMAL END OF THE GUIDE WIRE. A PTFE ADHESION TEST WAS PERFORMED AND REVEALED THAT COATING WAS WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY PROCEDURE MISSING COATING WAS NOTED ON THE GUIDE WIRE. THE PHYSICIAN SELECTED A CHOICE PT GUIDE WIRE AND REMOVED IT FROM THE PACKAGE WITHOUT ISSUE. ON UNPACKING THE DEVICE THE TIP WAS FOUND TO BE DAMAGED AND MISSING COATING ALONG 35CM OF THE GUIDE WIRE. THE DEVICE WAS NEVER IN CONTACT WITH THE PATIENT. ANOTHER DEVICE WAS SELECTED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY PROCEDURE MISSING COATING WAS NOTED ON THE GUIDE WIRE. THE PHYSICIAN SELECTED A CHOICE PT GUIDE WIRE AND REMOVED IT FROM THE PACKAGE WITHOUT ISSUE. ON UNPACKING THE DEVICE THE TIP WAS FOUND TO BE DAMAGED AND MISSING COATING ALONG 35CM OF THE GUIDE WIRE. THE DEVICE WAS NEVER IN CONTACT WITH THE PATIENT. ANOTHER DEVICE WAS SELECTED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7491216001J1 13581877

    Patients

    Seq Age Sex Outcome Treatment
    1