BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 4133657 · Received October 1, 2014

    Report

    Report Number
    2024168-2014-06354
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED PRODUCT WERE REVIEWED. THE STEERABLE GUIDING CATHETER (SGC) WAS RETURNED FOR ANALYSIS, WHICH CONFIRMED THAT THE HEMOSTASIS VALVE WAS LOOSE. A REVIEW OF THE LOT HISTORY RECORD WAS CONDUCTED AND FOUND NO ASSOCIATED NON-CONFORMING REPORTS FOR THIS LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER INCIDENTS RELATED TO DIFFICULTY INSERTING THE CLIP DELIVERY SYSTEM FOR THIS LOT. BASED ON THE RELATED RECORDS REVIEW, REVIEW OF THE LOT HISTORY REVIEW FOR THIS LOT AND COMPLAINT RATE, A POTENTIAL MALFUNCTION WAS IDENTIFIED. THERE IS NO INDICATION THAT A LARGER POPULATION IS PREDISPOSED TO RESISTANCE. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE PROCESSED PER LOCAL QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    THIS IS BEING FILED TO REPORT A STEERABLE GUIDING CATHETER HEMOSTASIS BOND BREAK FOUND DURING RETURNED DEVICE ANALYSIS WHICH HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE AIR LEAK IN ANATOMY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE STEERABLE GUIDING CATHETER (SGC 10289805/(B)(4)) WAS ADVANCED INTO THE ANATOMY. A CLIP DELIVERY SYSTEM (CDS) WAS ATTEMPTED TO BE INSERTED INTO THE SGC, BUT IT COULD NOT BE INSERTED INTO THE KEYWAY. THE BLUE LINES WERE CONFIRMED TO BE ALIGNED. THE CLIP INTRODUCER OF THE CDS WAS ROTATED CLOCKWISE AND COUNTER-CLOCKWISE, BUT IT COULD NOT BE INSERTED. IT WAS THEN FOUND THAT THE CLEAR HOUSING AT THE PROXIMAL END OF THE GUIDE WAS LOOSE, AND SPINNING. THE SGC WAS REMOVED AND REPLACED. THE NEW SGC WAS ADVANCED WITHOUT ISSUE. THE MR WAS REDUCED TO 1+ WITH THE IMPLANTATION OF 2 CLIPS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS, ON (B)(4) 2014, REVEALED THE REPORTED BREAK IN THE HEMOSTASIS VALVE WAS DUE TO A LOSS OF BOND ADHESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613385 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10289805

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM