BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4141129 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06432
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USED FOR CROOKED INSERTION OF THE CLIP DELIVERY SYSTEM THROUGH THE STEERABLE GUIDE CATHETER. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED TORN CLIP INTRODUCER (CI) TIP WAS CONFIRMED; HOWEVER, THE REPORTED DIFFICULTY INSERTING AND RETRACTING THE CLIP COULD NOT BE CONFIRMED VIA RETURNED DEVICE ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. IT SHOULD BE NOTED THAT THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, WHILE FLUSHING WITH HEPARINIZED SALINE ON THE GUIDE HEMOSTASIS VALVE, PLACE THE TIP OF THE CI AGAINST THE GUIDE HEMOSTASIS VALVE AND ADVANCE THE CI STRAIGHT INTO THE VALVE IN A CONTINUOUS MOTION WHILE ROTATING THE CLIP INTRODUCER IN SMALL CLOCKWISE AND COUNTERCLOCKWISE MOTIONS UNTIL THE CLIP CAN BE OBSERVED DISTAL TO THE VALVE. THE CI SHOULD ADDITIONALLY BE FULLY INSERTED INTO THE GUIDE HEMOSTASIS VALVE THROUGHOUT THE ENTIRE PROCEDURE. THE IFU ALSO WARNS THAT IF THE GUIDE HEMOSTASIS VALVE, CI, OR CLIP BECOMES DAMAGED, THIS MAY RESULT IN AIR EMBOLISM, VASCULAR, OR CARDIAC INJURY. IT WAS REPORTED THAT THE CI WAS HALF WAY INSERTED INTO THE HEMOSTASIS VALVE WHEN THE PHYSICIAN PUSHED ON THE STEERABLE SLEEVE AND THE CI WENT IN CROOKED, ALLOWING AIR TO ENTER THE HEMOSTASIS VALVE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED PATIENT WEIGHT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE SGC REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED FOR THE DIFFICULT TO REMOVE CLIP DELIVERY SYSTEM (CDS). DIFFICULTY REMOVING THE CDS HAS POTENTIAL FOR INJURY. IT WAS REPORTED THAT THE MITRACLIP STEERABLE GUIDE CATHETER (SGC) WAS IN THE ANATOMY WHEN THE CDS WAS BEING INSERTED THROUGH THE SGC WITHOUT RESISTANCE. THE CLIP INTRODUCER (CI) WAS HALF WAY INSIDE THE HEMOSTATIC VALVE WHEN THE STEERABLE SLEEVE WAS PUSHED AND THE CI WENT IN CROOKED, WHICH ALLOWED AIR TO ENTER THE HEMOSTATIC VALVE. THE CDS WAS PULLED BACK, BUT THE CLIP CAUGHT ON THE CI AND FRAYED THE TIP OF THE CI. AFTER THE CDS WAS REMOVED FROM THE SGC, THE AIR WAS ASPIRATED OUT OF THE HEMOSTATIC VALVE. ANOTHER CDS WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. ONE MITRACLIP WAS IMPLANTED IN THE PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) REDUCING THE MR FROM 4+ TO 1 TO 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618240 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 40619U1

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR STEERABLE GUIDE CATHETER