BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI MICROCATHETER 18L

    MDR report key: 2364654 · Received October 2, 2008

    Report

    Report Number
    2954917-2008-00012
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    June 11, 2008
    Report Date
    October 1, 2008
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K003086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE THREE MERCI MICROCATHETER 18L DEVICES WERE NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE MANUFACTURING RECORD FOR MICROCATHETER 18L DEVICES THAT WERE SHIPPED TO THE SITE, LOT NUMBER 33015, WAS REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    PER MEDWATCH USER FACILITY REPORTS (B)(4) RECEIVED VIA FAX ON 09/02/2008, TWO (2) SEPARATE 8F BALLOON GUIDE CATHETERS DEFLATED SLOWLY IN THE SAME PATIENT. THE QUALITY CONTROL COORDINATOR AT THE SITE CONFIRMED THAT THE INCIDENT DATE WAS (B)(6) 2008 AS WAS STATED ON THE MEDWATCH USER FACILITY REPORTS. ALSO, SHE INDICATED THAT THERE WAS "NO ILL OUTCOME" FOR THE PATIENT ASSOCIATED WITH THE EVENTS. REPEATED ATTEMPTS WERE MADE TO GET MORE INFORMATION FROM THE SITE. HOWEVER, AS OF 10/01/2008, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE SITE WOULD NOT RETURN THE DEVICES TO CONCENTRIC FOR EVALUATION. IN ADDITION, THEY DID NOT PROVIDE ANY INFORMATION REGARDING EXACTLY HOW THE DEVICE WERE USED OR HOW SLOWLY THE BALLOONS DEFLATED SO WE COULD DETERMINE WHETHER OUR INSTRUCTIONS FOR USE WERE FOLLOWED OR OUR SPECIFICATIONS WERE MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 33015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR