BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3844296 · Received June 2, 2014

    Report

    Report Number
    2024168-2014-03541
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CLIP DELIVERY SYSTEM (CSD) WAS RETURNED AND THE REPORTED ACTUATOR KNOB DETACHMENT WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. THE MATING SURFACES BETWEEN THE TWO PIECES (ACTUATOR KNOB AND RELEASE CRIMPER) WERE EXAMINED NEXT TO DETERMINE THE CAUSE OF THE DETACHMENT. ADHESIVE (LOCTITE) WAS VERIFIED TO BE PRESENT INSIDE THE ACTUATOR KNOB AND ON THE RELEASE CRIMPER. THE ADHESIVE WAS TACTILELY EXAMINED AND IDENTIFIED TO BE HARD, AND THUS FULLY CURED. THE ACTUATOR KNOB SURFACE WAS INSPECTED NEXT AND SLIGHT INDENTATION WAS NOTED ON ONE SIDE OF THE KNOB. THIS WAS LIKELY DUE TO THE IMPACT FROM THE KNOB DETACHING. POTENTIAL CAUSES FOR ACTUATOR KNOB DETACHMENT CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING ANOMALIES (LOCTITE AND / OR ACCELERATOR NOT APPLIED OR FULLY CURED, RESULTING IN DETACHMENT) PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY / PATHOLOGY), USER TECHNIQUE / HANDLING DURING PREPARATION OR PROCEDURAL CONDITIONS (EXCESSIVE TENSION ON THE DEVICE DURING PROCEDURE). AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL CLIP DELIVERY SYSTEMS ARE SUBJECT TO VISUAL AND DIMENSIONAL INSPECTION TO VERIFY PRODUCT QUALITY INCLUDING VERIFICATION THAT THE KNOB IS ATTACHED TO THE RELEASE CRIMPER. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS. THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS REPORTED FOR ACTUATOR KNOB DETACHMENT FROM THIS LOT. AS THE DEVICE HAD NOT BEEN USED IN PATIENT, PATIENT / PROCEDURAL CONDITIONS CAN BE RULED OUT AS A CONTRIBUTORY CAUSE TO THIS INCIDENT. WITH RESPECT TO USER TECHNIQUE/HANDLING, THE DETACHMENT OF THE ACTUATOR KNOB CAN BE INFLUENCED BY THE STEPS UTILIZED AT THE ACCOUNT TO REMOVE THE DEVICE (PACKAGING TRAY) FROM THE SHELF CARTON DURING DEVICE PREPARATION. IT WAS VERIFIED VIA DEVICE ANALYSIS THAT THE LOCTITE WAS PRESENT INSIDE THE ACTUATOR KNOB AND ON THE RELEASE CRIMPER, AND WAS IDENTIFIED TO BE FULLY CURED. ADDITIONALLY, THE ACTUATOR KNOB WAS FURTHER ANALYZED VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND THE ANALYSIS CONFIRMED THE PRESENCE OF LOCTITE AND ACCELERATOR INSIDE THE ACTUATOR KNOB. IN THIS CASE, IT IS POSSIBLE THAT THE ACTUATOR KNOB DETACHED FROM INADVERTENT GENERAL HANDLING OF THE DEVICE DURING PREPARATION PRIOR TO REMOVING THE CDS FROM THE PACKAGING TRAY; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE ACTUATOR KNOB DETACHMENT COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THIS IS FILED AFTER THE CLIP DELIVERY SYSTEM WAS UNBOXED, THE ACTUATOR KNOB WAS OBSERVED TO BE DETACHED FROM THE DEVICE. ALTHOUGH THERE WAS NO PATIENT INVOLVEMENT, IF THIS WERE TO RECUR AND THE DEVICE WAS USED IN THE PROCEDURE, THERE IS POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT PRIOR TO A MITRACLIP PROCEDURE, THE CLIP DELIVERY SYSTEM WAS UNBOXED AND HANDED OVER TO THE PHYSICIAN IN THE PREFORMED TRAY TO PREP AND DE-AIR. BEFORE REMOVING THE DEVICE FROM THE TRAY, IT WAS NOTED THAT THE BLUE ACTUATOR KNOB WAS NOT ATTACHED TO THE CDS AND WAS IN THE PACKAGING TRAY. THE PREP OF THE DEVICE WAS NOT PERFORMED. THE DEVICE WAS NOT USED; THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE INTENDED PROCEDURE DUE TO THE DEVICE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322349 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10284035

    Patients

    Seq Age Sex Outcome Treatment
    1