BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? COACCESS?

    MDR report key: 4210569 · Received October 29, 2014

    Report

    Report Number
    2134265-2014-07009
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RECEIVED ONE COACCESS ELECTRODE, CABLE AND INTRODUCER WITH NO VISIBLE RESIDUE FOUND ON THE DEVICE. THE INTRODUCER AND CABLE WERE WITHOUT ISSUE. A VISUAL EXAMINATION OF THE DEVICE FOUND THE TINES TO BE FULLY RETRACTED. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING AND RETRACTING THE ARRAY WITHOUT ISSUE. THE TINES WERE FOUND TO BE UN-EVENLY SPACED AND BENT. 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 DIFFICULTY EXTENDING THE NEEDLE OCCURRED. WHEN FUNCTIONAL TESTING WAS PERFORMED DURING PREPARATION, THE TARGET SITE WAS PUNCTURED WITH THE LEVEEN¿ COACCESS¿ ELECTRODE SYSTEM 4.0/15/15, HOWEVER, THE NEEDLE FAILED TO FULLY EXTEND. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN¿ COACCESS¿ SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY EXTENDING THE NEEDLE OCCURRED. WHEN FUNCTIONAL TESTING WAS PERFORMED DURING PREPARATION, THE TARGET SITE WAS PUNCTURED WITH THE LEVEEN COACCESS ELECTRODE SYSTEM 4.0/15/15 HOWEVER THE NEEDLE FAILED TO FULLY EXTEND. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691962 LEVEEN? COACCESS? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262240 16624973

    Patients

    Seq Age Sex Outcome Treatment
    1