BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT - BALLOON CATHETER

    MDR report key: 4090995 · Received September 16, 2014

    Report

    Report Number
    1226348-2014-00638
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    MJN
    PMA / PMN Number
    K080861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCATION OF THE LEAK NOTICED BY THE USER WAS NOT SPECIFIED IN THE PRODUCT COMPLAINT INFORMATION REPORT. WATER WAS INJECTED THROUGH THE BALLOON PORT AND DROPS OF WATER WERE OBSERVED COMING FROM THE BALLOON AREA. A VISUAL INSPECTION USING A REGULAR MICROSCOPE SHOWED A LONGITUDINAL TEAR APPROXIMATELY 15 MM FROM THE PROXIMAL SEAL TO THE DISTAL SEAL IN THE BALLOON AREA. NO DEFECTS WERE FOUND DURING VISUAL INSPECTION IN THE OUTER CATHETER SURFACE. THE COMPLAINT IS CONFIRMED. THE LENGTH BETWEEN THE PROXIMAL SEAL AND THE DISTAL SEAL WAS ALMOST 15 MM WHICH MEANS THAT THE BALLOON WAS OVER STRETCHED AND AS A RESULT THE UNIT WAS DAMAGED. PRIOR INVESTIGATIONS REVEALED THAT ONE OF THE POSSIBLE FAILURES WHEN THE BALLOON IS OVER INFLATED IS THE OCCURRENCE OF LEAKS WHICH, WITH ADDITIONAL PRESSURE ON THE BALLOON,MAY LEAD TO LONGITUDINAL TEARS. THEREFORE,, THE ROOT CAUSE APPEARS TO BE BALLOON OVER INFLATION. ONE HUNDRED (100) % LEAK TESTING IS PERFORMED ON EACH BALLOON CATHETER BEFORE IT IS RELEASED TO DETERMINE WHETHER OR NOT THE BALLOON LEAKS, SO THIS BALLOON CATHETER COULD NOT HAVE LEFT MANUFACTURING WITH A LEAK OR A RUPTURE. IN ADDITION TO THAT A REVIEW OF MANUFACTURING RECORDS (DHR) FOR LOT NUMBER F61162 REFERENCED IN THE COMPLAINT WAS CONDUCTED. ALL WERE FOUND TO BE COMPLETE. NO OUTSTANDING DISCREPANCIES, DESIGN, QUALITY CONCERNS OR HIGHER THAN NORMAL REJECTS WERE FOUND. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    WHEN THE BALLOON CATHETER WAS TAKEN OUT OF THE BOX; DURING PREPARATION THE BALLOON SHOWED LEAKAGE. A NEW BALLOON CATHETER WAS TAKEN OUT, PREPARED, AND THE PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570976 ASCENT - BALLOON CATHETER CES BALLOON CATHETER MJN MICRUS ENDOVASCULAR, LLC NA F61162

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR