BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 3981393 · Received August 5, 2014

    Report

    Report Number
    2024168-2014-04953
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STEERABLE GUIDE CATHETER (SGC) WAS RETURNED. THE DILATOR WAS NOT RETURNED. THE HEMOSTASIS VALVE WAS CONFIRMED TO BE INTACT AND THERE WAS NO EXTERNAL DAMAGE OBSERVED TO THE DEVICE. THERE WAS EVIDENCE OF SILICONE IN THE SGC VALVE CHAMBER. IN AN EFFORT TO CONFIRM THE REPORTED LEAK, THE SGC WAS CONNECTED TO A LEAK TESTER TO PERFORM AIR LEAK TESTING AND THE DEVICE PASSED THE LEAK TEST ALL 3 TIMES. ADDITIONALLY, NO AIR BUBBLES WERE OBSERVED IN THE SYRINGE THAT WAS BEING USED TO ASPIRATE DURING RETRACTION. THUS, THE REPORTED LEAK WAS NOT CONFIRMED VIA RETURNED DEVICE TESTING. POTENTIAL CAUSES FOR LEAKS CAN INCLUDE, BUT ARE NOT LIMITED TO, USER TECHNIQUE/PROCEDURAL CONDITIONS, SUCH AS THE STEPS UTILIZED TO DE-AIR THE DEVICE DURING GUIDE PREPARATION OR LOOSE CONNECTIONS BETWEEN THE LUER AND ACCESSORY DEVICES (I.E. STOPCOCK, HIGH PRESSURE TUBING OR SYRINGE) OR MANUFACTURING ANOMALIES (TEARS OR MISSING SILICONE IN THE VALVE). REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING A LEAK TEST AND VERIFICATION THAT SILICONE WAS APPLIED TO THE GUIDE VALVE. ADDITIONALLY, THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE ELECTRONIC COMPLAINT HISTORY FOUND NO OTHER INCIDENTS REPORTED FROM THIS LOT. THE USER ALSO REPORTED NO ISSUES DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. THERE IS NO INDICATION THAT THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. EVALUATION SUMMARY: WITH RESPECT TO USER TECHNIQUE/PROCEDURAL CONDITIONS, LEAKS MAY BE INFLUENCED BY THE STEPS UTILIZED DURING DEVICE PREPARATION, SUCH AS NOT FULLY DE-AIRING THE GUIDE SHAFT DURING PREPARATION, LOOSE CONNECTIONS BETWEEN THE LUER PORT AND ACCESSORY DEVICES (I.E. STOPCOCK, HIGH PRESSURE TUBING OR SYRINGE) OR THE GUIDE COMING INTO CONTACT WITH THE ATRIAL WALL, RESULTING IN A VACUUM EFFECT. SINCE THE ANALYSIS WAS UNABLE TO IDENTIFY ANY LEAKS IN THE VALVE DURING TESTING AND THE DEVICE FUNCTIONED AS INTENDED, IT IS POSSIBLE THAT THE LEAK (AIR) OBSERVED IN THE SYSTEM WAS RELATED TO USER TECHNIQUE/PROCEDURAL CONDITIONS DURING USE; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED LEAK COULD NOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    THIS IS BEING FILED AS DURING REMOVAL OF THE STEERABLE GUIDE CATHETER DILATOR, AIR WAS ASPIRATED AND THE SOURCE OF THE AIR WAS NOT KNOWN. ALTHOUGH THERE WAS NO ADVERSE PATIENT EFFECT, AIR IN THE ANATOMY HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THE MITRACLIP STEERABLE GUIDE CATHETER (SGC) WAS PREPARED FOR USE AS PER THE INSTRUCTIONS FOR USE AND THE SYSTEM WORKED WITHOUT ISSUES. AFTER THE SGC WAS INSERTED INTO THE LEFT ATRIUM, THE DEVICE WAS POSITIONED SO THE TIP WAS FREE FROM CONTACT WITH THE LEFT ATRIUM WALL. AFTER THE DILATOR WAS RETRACTED APPROXIMATELY 15CM, AIR WAS SEEN IN THE SYRINGE THAT WAS BEING USED TO ASPIRATE DURING RETRACTION. IT COULD NOT BE DETERMINED WHERE THE AIR CAME FROM. THE DILATOR DID NOT APPEAR TO BE RETRACTED TOO QUICKLY; NO RESISTANCE WAS FELT DURING THE RETRACTION OF THE DILATOR. ASPIRATION WAS PERFORMED AGAIN AND THEN SGC WAS RETRACTED INTO THE RIGHT ATRIUM. THE SGC WAS REMOVED FROM THE ANATOMY. A NEW TRANSSEPTAL PUNCTURE WAS PERFORMED AND ANOTHER SGC WAS USED FOR THE PROCEDURE WITH NO PROBLEMS. THERE WAS NO ADVERSE PATIENT EFFECT OR SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE FUNCTIONAL MITRAL REGURGITATION GRADE WAS REDUCED FROM 3-4 TO 1 WITH THE IMPLANTATION OF ONE CLIP. THE PATIENT WAS STABLE POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457503 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10323965

    Patients

    Seq Age Sex Outcome Treatment
    1 MITRACLIP SYSTEM