BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 3902349 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04213
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K112239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: THE PACEMAKER PACED AT 60 BEATS PER MINUTE, BUT THE ELECTROMECHANICAL DISASSOCIATION REMAINED. CPR WAS TEMPORARILY PAUSED IN ORDER TO PULL THE CDS INTO THE SGC, BUT ONE ARM OF THE CLIP BECAME STUCK AT THE SOFT TIP OF THE SGC. THE ENTIRE SYSTEM WAS REMOVED AS A SINGLE UNIT AND CPR WAS RESUMED FOR MORE THAN ONE HOUR. THE PATIENT EXPIRED. ALTHOUGH THE PHYSICIAN DOES NOT FEEL THAT THESE EVENTS WERE CAUSED BY A FAILURE OF THE MITRACLIP SYSTEM, THE PHYSICIAN DOES FEEL THAT THE TIP OF THE SGC PERFORATED THE ATRIAL ROOF. THE PHYSICIAN ALSO FEELS THAT THE MITRACLIP WENT THROUGH THE ATRIAL PERFORATION WHEN THE SHAFT WOULD NOT STEER DOWN, RESULTING IN THE PERICARDIAL EFFUSION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE RETURNED DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE MITRACLIP DELIVERY SYSTEM REFERENCED IS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED. THERE WAS EVIDENCE OF SILICONE PRESENT IN THE VALVE CHAMBER. THE REPORTED LEAK COULD NOT BE CONFIRMED VIA RETURNED DEVICE ANALYSIS. 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). AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL STEERABLE GUIDE CATHETERS ARE SUBJECT TO VISUAL AND FUNCTIONAL INSPECTION TO VERIFY PRODUCT QUALITY. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT INDICATED THERE HAVE BEEN NO OTHER INCIDENTS OF LEAK REPORTED FOR THIS LOT. THERE WERE ALSO NO REPORTED ISSUES DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. WITH RESPECT TO USER TECHNIQUE/PROCEDURAL CONDITIONS, LEAKS MAY BE INFLUENCED BY THE STEPS UTILIZED AT THE ACCOUNT DURING DEVICE PREPARATION, SUCH AS NOT FULLY DE-AIRING THE GUIDE SHAFT DURING GUIDE 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. THE INFORMATION PROVIDED IN THE CASE DETAILS STATED THAT ONCE THE WIRE WAS RETRACTED INTO THE DILATOR, ECHOCARDIOGRAPHY CONFIRMED THAT THE END OF THE SGC WAS FREE. HOWEVER, AFTER ASPIRATING THE SGC WHILE RETRACTING THE DILATOR AND COVERING THE VALVE, IT WAS OBSERVED THAT THE HEMOSTASIS VALVE WAS PARTIALLY FILLED WITH FLUID. ECHOCARDIOGRAM THEN SHOWED THAT THE TIP OF THE SGC WAS AT THE ATRIAL ROOF. THE PHYSICIAN RETRACTED THE SGC, ASPIRATED AGAIN, AND THE HEMOSTASIS VALVE WAS DE-AIRED. IN THIS CASE, AS THE DEVICE FUNCTIONED AS INTENDED WITH NO LEAKS IDENTIFIED DURING RETURNED DEVICE ANALYSIS, IT IS LIKELY THAT THE GUIDE CAME INTO CONTACT WITH THE WALL OF THE ATRIUM WHILE ASPIRATING THE GUIDE AND RESULTED IN THE PARTIAL LOSS OF FLUID COLUMN. BASED ON THE INFORMATION PROVIDED, THE REPORTED LEAK APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS/USER TECHNIQUE. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, DEVICE ANALYSIS REVEALED THE SOFT TIP OF THE SGCE TORN AND ALL SOFT TIP MATERIAL WAS PRESENT. TEARS IDENTIFIED IN THE SOFT TIP ARE INDICATIVE OF THE CLIP GETTING CAUGHT ON THE GUIDE TIP DURING REMOVAL OF THE CDS, AS REPORTED. BASED ON THE INFORMATION REVIEWED, THE TORN SOFT TIP MATERIAL APPEARS TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CONDITIONS AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    THIS STEERABLE GUIDE CATHETER (SGC) REPORT IS BEING FILED FOR THE AIR FOUND IN THE DEVICE DURING USE, ATRIAL PERFORATION, PERICARDIAL EFFUSION, AND DEATH. IT WAS REPORTED THAT THE TRANSSEPTAL PUNCTURE WITH ADEQUATE HEIGHT AND PLACEMENT WAS PERFORMED. THE EXTRASTIFF GUIDE WIRE WAS IN THE LEFT UPPER PULMONARY VEIN AND THE SGC WAS ADVANCED TO THE LEFT ATRIUM. THE DILATOR WAS PULLED INTO THE GUIDE, THEN THE GUIDEWIRE WAS PULLED IN THE DILATOR AND ECHOCARDIOGRAPHY CONFIRMED THAT THE END OF THE SGC WAS FREE. ASPIRATION AND RETRACTION OF THE DILATOR FROM THE SGC WAS PERFORMED AND THE HEMOSTASIS VALVE WAS COVERED WITH THE PHYSICIAN'S THUMB. AT THAT MOMENT, IT WAS SEEN THAT THE HEMOSTASIS VALVE WAS ONLY HALF FILLED WITH FLUID. ECHOCARDIOGRAM SHOWED THAT THE TIP OF THE SGC WAS AT THE ATRIAL ROOF SO THE PHYSICIAN RETRACTED THE SGC, ASPIRATED AGAIN, AND THE HEMOSTASIS VALVE WAS DE-AIRED. VIA ECHOCARDIOGRAM THE SGC APPEARED TO BE FREE FROM THE ATRIUM AND THE CDS WAS ADVANCED. AFTER THE CDS REACHED THE STRADDLING POSITION, VIA FLUOROSCOPY AND ECHOCARDIOGRAM, THE CLIP APPEARED TO BE FREE FROM THE ATRIUM AND AN ATTEMPT WAS MADE TO STEER DOWN TO THE VALVE. THE CDS SHAFT APPEARED STUCK IN THE LEFT ATRIUM AND WOULD NOT MOVE. WHEN MORE M KNOB WAS APPLIED, THE CDS SHAFT WAS IN A CURVED SHAPE WITH A LITTLE DEFLECTION. AT THAT TIME, THE ECHOCARDIOGRAPHER DETECTED A PERICARDIAL EFFUSION AND THE PATIENT HAD NO BLOOD PRESSURE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND A TEMPORARY PACEMAKER WAS IMPLANTED. THERE WAS AN ELECTROMECHANICAL DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379472 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 10287335

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death MITRACLIP DELIVERY SYSTEM